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BioNTech SE (BNTX) Report Analysis

Corporate Events

Positive

BioNTech SE and Ryvu Therapeutics S.A. Enters i...

2022-11-30 06:02:00

BioNTech SE and Ryvu Therapeutics S.A. announced that the companies have entered into a multi-target research collaboration for several small ...

Neutral

Shanghai Fosun Pharmaceutical (Group) Co., Ltd....

2022-11-18 14:51:00

Shanghai Fosun Pharmaceutical (Group) Co. Ltd. announced that references are made to the overseas regulatory announcements of the Company date...

Positive

Pfizer and BioNTech Report New Data on Omicron ...

2022-11-18 11:45:00

Pfizer Inc. and BioNTech SE announced results from an analysis examining the immune response induced by their Omicron BA.4/BA.5-adapted bivale...

Positive

Pfizer Inc. and BioNTech SE Advances Next-Gener...

2022-11-16 23:30:00

Pfizer Inc. and BioNTech SE announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicit...

Positive

Pfizer and Biontech Receive Positive Chmp Opini...

2022-11-10 14:45:00

Pfizer Inc. and BioNTech SE announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicro...

Positive

BioNTech Seeks M&A Opportunities

2022-11-07 13:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for M&A opportunities. Ryan Richardson, Chief Strategy Officer said, "We will also continue to look for...

Positive

BioNTech SE Se Revises Its Earnings Guidance fo...

2022-11-07 11:08:00

BioNTech SE revised its earnings guidance for the full year 2022. For the year, BioNTech updates its 2022 financial guidance, raising its COVI...

Positive

Pfizer Inc. and BioNTech SE Announces Updated C...

2022-11-04 10:47:00

Pfizer Inc. and BioNTech SE announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-mon...

Neutral

BioNTech SE Presents at TIDES Europe 2022, Nov-...

2022-11-03 08:12:00

BioNTech SE Presents at TIDES Europe 2022, Nov-16-2022 through Nov-18-2022. Venue: Vienna, Austria. Presentation Date & Speakers: Nov-18-2022,...

Positive

Pfizer and Biontech Receive Positive CHMP Opini...

2022-10-19 15:45:00

Pfizer Inc. and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rec...

Neutral

Informa plc, TIDES Europe 2022, Nov 16, 2022 th...

2022-10-18 07:11:00

Informa plc, TIDES Europe 2022, Nov 16, 2022 through Nov 18, 2022. Venue: Vienna, Austria.

Positive

Pfizer and BioNTech Announce Positive Early Dat...

2022-10-13 10:45:00

On October 13, 2022, Pfizer Inc. and BioNTech SE announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tol...

Positive

Pfizer and BioNTech Receive U.S. FDA Emergency ...

2022-10-12 14:16:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg b...

Positive

Pfizer Canada ULC and BioNTech SE's Omicron Ba....

2022-10-07 15:00:00

Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized COMIRNATY Original & Omicron BA.4/BA.5 as a 30-µg booster dose f...

Positive

BioNTech SE and Australia’s State of Victoria F...

2022-10-06 23:30:00

BioNTech SE announced that it has agreed a Letter of Intent with the State of Victoria in Australia on a strategic partnership between the Sta...

Positive

Pfizer and BioNTech Submit Application to U.S. ...

2022-09-26 10:45:00

Pfizer Inc. and BioNTech SE announced they have completeda submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use ...

Neutral

BioNTech SE Presents at 22nd Annual Biotech in ...

2022-09-16 19:08:00

BioNTech SE Presents at 22nd Annual Biotech in Europe Forum, Sep-21-2022 .

Positive

Pfizer Inc. and BioNTech SE Receive Positive Ch...

2022-09-16 12:00:00

Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ha...

Neutral

BioNTech SE Presents at Longwood Healthcare Lea...

2022-09-15 15:45:00

BioNTech SE Presents at Longwood Healthcare Leaders Fall Webconference, Sep-21-2022 08:50 AM. Speakers: Ryan Richardson, Chief Strategy Office...

Positive

Pfizer and BioNTech SE Receive Positive CHMP Op...

2022-09-12 15:20:00

Pfizer Inc. and BioNTech SE announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/O...

Neutral

BioNTech SE Presents at European Society for Me...

2022-09-09 14:30:00

BioNTech SE Presents at European Society for Medical Oncology (ESMO) Annual Congress 2022, Sep-09-2022 . Venue: Paris Expo Porte de Versailles...

Positive

Biontech Presents Encouraging Phase 1/2 Follow-...

2022-09-09 14:30:00

BioNTech SE presented positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Compan...

Neutral

Longwood, Longwood Healthcare Leaders Fall Webc...

2022-09-08 20:05:00

Longwood, Longwood Healthcare Leaders Fall Webconference, Sep 21, 2022 through Sep 22, 2022.

Positive

Pfizer Inc. and BioNTech SE Receive Positive CH...

2022-09-01 13:45:00

Pfizer Inc. and BioNTech SE announced a 30 µg booster dose of their Omicron BA.1- Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 ...

Positive

Pfizer and BioNTech Granted FDA Emergency Use A...

2022-08-31 14:12:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg bo...

Positive

Pfizer and BioNTech Complete Submission to Euro...

2022-08-26 13:52:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron...

Positive

Pfizer Inc. and BioNTech SE Complete Submission...

2022-08-26 13:45:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron...

Neutral

BioNTech SE Presents at 5th HKEX Biotech Summit...

2022-08-23 13:20:00

BioNTech SE Presents at 5th HKEX Biotech Summit 2022, Sep-01-2022 10:20 AM. Speakers: Ugur Sahin, Co-Founder, CEO & Chair of the Management Board.

Neutral

Hong Kong Exchanges and Clearing Limited, 5th H...

2022-08-23 11:30:00

Hong Kong Exchanges and Clearing Limited, 5th HKEX Biotech Summit 2022, Sep 01, 2022.

Positive

Pfizer and BioNTech Announce Updated COVID-19 V...

2022-08-23 10:45:00

Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTe...

Positive

Pfizer and Biontech Submits Application to U.S....

2022-08-22 14:30:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use...

Neutral

BioNTech SE Presents at World Vaccine Congress ...

2022-08-18 04:38:00

BioNTech SE Presents at World Vaccine Congress Europe 2022, Oct-11-2022 through Oct-14-2022. Venue: Palau de Congressos de Barcelona, FIRA Mon...

Neutral

BioNTech SE Presents at Onco Cell Therapy Summi...

2022-08-12 13:56:00

BioNTech SE Presents at Onco Cell Therapy Summit Europe 2022, Nov-02-2022 . Venue: Amsterdam, Netherlands. Speakers: Benjamin Rengstl, Directo...

Neutral

Kisaco Research, Onco Cell Therapy Summit Europ...

2022-08-12 11:30:00

Kisaco Research, Onco Cell Therapy Summit Europe 2022, Nov 02, 2022 through Nov 03, 2022. Venue: Amsterdam, Netherlands.

Neutral

BioNTech SE Presents at Berenberg & Goldman Sac...

2022-08-12 10:45:00

BioNTech SE Presents at Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep-20-2022 04:30 PM. Venue: Infinity Munich Hotel, A...

Positive

BioNTech Seeks Acquisitions

2022-08-08 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Ryan Richardson,Chief Strategy Officer said, "So we are looking at a wide range of op...

Neutral

BioNTech Reiterates Revenue Guidance for the Fu...

2022-08-08 10:00:00

BioNTech Reiterates revenue guidance for the full year 2022. The company estimated BioNTech COVID-19 vaccine revenues for the full 2022 financ...

Neutral

Tranche Update on BioNTech SE (NasdaqGS:BNTX)'s...

2022-08-08 07:18:00

From April 1, 2022 to June 30, 2022, the company has repurchased 2,078,207 shares, representing 0.86% for $302.69 million. With this, the comp...

Positive

Genmab A/S and BioNTech SE Expand Global Strate...

2022-08-05 10:45:00

Genmab A/S and BioNTech SE announced an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies f...

Positive

Pfizer and BioNTech Advance COVID-19 Vaccine St...

2022-07-27 10:45:00

Pfizer Inc. and BioNTech SE announced that the companies have initiated a randomized, active-controlled, observer-blind Phase 2 study to evalu...

Positive

Pfizer Inc. and BioNTech SE Submits Variation t...

2022-07-11 10:06:00

Pfizer Inc. and BioNTech SE submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Author...

Positive

Pfizer and BioNTech Announce U.S. FDA Approval ...

2022-07-08 21:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) approved the companies' supplemental Biologics License Appli...

Negative

CureVac Files Patent Infringement Lawsuit in Ge...

2022-07-05 11:00:00

CureVac N.V. announced that it has moved to assert its intellectual property rights, accumulated over more than two decades of pioneering work...

Neutral

BioNTech SE Presents at 2022 Nordic Life Scienc...

2022-06-30 08:51:00

BioNTech SE Presents at 2022 Nordic Life Science days, Sep-28-2022 04:00 PM. Venue: Malmo, Sweden. Speakers: Holger Kissel, Vice President Bus...

Neutral

Pfizer Inc. and BioNTech SE Announces New Agree...

2022-06-29 20:45:00

Pfizer Inc. and BioNTech SE announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19....

Positive

Pfizer and BioNTech Announce Omicron-Adapted CO...

2022-06-25 14:00:00

Pfizer Inc. and BioNTech SE announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 va...

Positive

BioNTech SE Receives Priority Medicines (PRIME)...

2022-06-23 15:00:00

BioNTech SE announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech’s fully owned pr...

Positive

BioNTech Starts Construction of First mRNA Vacc...

2022-06-23 10:00:00

BioNTech SE has reached the next milestone in the establishment of scalable mRNA vaccine production in Africa on its planned schedule. Today, ...

Neutral

BioNTech SE - Special Call

2022-06-20 15:30:00

To provide an update on BioNTech's clinical progress across its pipeline and provide a deep-dive on scientific and technology innovation from ...

Positive

Pfizer and BioNTech COVID-19 Vaccine Receives F...

2022-06-17 13:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioN...

Neutral

BioNTech SE - Special Call

2022-06-09 12:31:00

To provide an Update on Manufacturing and Development Plans of mRNA Vaccines in Africa

Neutral

BioNTech SE Presents at 2022 Jefferies Global H...

2022-06-07 20:15:00

BioNTech SE Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM. Venue: Marriott Marquis, New York City, New York, U...

Positive

BioNTech SE Announces Positive Phase 1 Data fro...

2022-06-05 16:30:00

BioNTech SE announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability ...

Negative

BioNTech SE Approves Board Appointments

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl a...

Positive

BioNTech SE Approves Special Cash Dividend

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved special cash dividend of EUR 2.00 per ordinary share (in...

Neutral

BioNTech SE Presents at Goldman Sachs 43rd Annu...

2022-05-31 14:08:00

BioNTech SE Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 02:00 PM. Venue: Terranea Resort, Rancho Palos Ver...

Positive

Pfizer-BioNTech COVID-19 Vaccine Demonstrates S...

2022-05-23 10:45:00

Pfizer Inc. and BioNTech SE announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg ...

Negative

BioNTech SE and Pfizer Inc. Announces the U.S. ...

2022-05-17 21:14:00

On May 17, 2022, BioNTech SE and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) ...

Positive

Pfizer and BioNTech SE Granted U.S. Emergency U...

2022-05-17 15:40:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a boos...

Positive

Pfizer and BioNTech Provide Update on COVID-19 ...

2022-05-16 11:49:00

Pfizer Inc. and BioNTech SE announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contra...

Neutral

BioNTech SE Presents at 8th Annual Immuno-Oncol...

2022-05-11 14:52:00

BioNTech SE Presents at 8th Annual Immuno-Oncology Innovation Forum, May-25-2022 01:10 PM.

Positive

BioNTech SE Proposes Special Cash Dividend

2022-05-09 10:01:00

The management board and supervisory board of BioNTech SE have proposed a special cash dividend of €2.00 per ordinary share (including those h...

Neutral

BioNTech SE Reiterates Earnings Guidance for th...

2022-05-09 10:01:00

BioNTech SE reiterated earnings guidance for the year 2022. The company reiterates its prior 2022 financial year outlook.

Neutral

Tranche Update on BioNTech SE (NasdaqGS:BNTX)'s...

2022-05-09 07:06:00

From March 31, 2022 to March 31, 2022, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has comple...

Positive

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

2022-04-27 00:00:00

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

Positive

BioNTech SE and Pfizer Inc. Submits Application...

2022-04-26 21:11:00

On April 26, 2022, BioNTech SE and Pfizer Inc. submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Autho...

Neutral

BioNTech SE Presents at TIDES (Oligonucleotide ...

2022-04-23 17:57:00

BioNTech SE Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022 . Venue: Boston, Massachusetts, United States. Speakers: A...

Neutral

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Th...

2022-04-23 07:45:00

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022. Venue: Boston, Massachusetts, United States.

Neutral

Biontech Se Proposes Amendment to Its Articles ...

2022-04-21 10:07:00

Currently, the Supervisory Board consists of four members according to Sec. 9 para. 1 of the Articles of Association of the Biontech Se. The n...

Neutral

BioNTech SE - Shareholder/Analyst Call

2022-04-21 10:07:00

Annual General Meeting

Neutral

BioNTech SE Presents at 5th European Neoantigen...

2022-04-15 10:08:00

BioNTech SE Presents at 5th European Neoantigen Summit 2022, Apr-27-2022 05:00 PM. Venue: Amsterdam, Netherlands. Speakers: Heinrich Haas, Vic...

Positive

Pfizer Inc. and BioNTech SE Announce Data Demon...

2022-04-14 10:46:00

Pfizer Inc. and BioNTech SE announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity ...

Positive

BioNTech SE announced that it has received $149...

2022-04-14 00:00:00

On April 14, 2022, BioNTech SE closed the transaction. The company received $149,999,985 in the transaction. The transaction included particip...

Positive

BioNTech and Matinas BioPharma Announce Exclusi...

2022-04-11 11:00:00

BioNTech SE and Matinas BioPharma announced that they have entered into an exclusive research collaboration to evaluate the combination of mRN...

Positive

BioNTech Presents Positive Preliminary Phase 1/...

2022-04-11 07:55:00

BioNTech SE presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company’s nov...

Neutral

BioNTech SE Receives Pandemic Preparedness Cont...

2022-04-08 13:24:00

BioNTech SE announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Ger...

Neutral

Terrapinn Limited, World Vaccine Congress Europ...

2022-04-03 10:12:00

Terrapinn Limited, World Vaccine Congress Europe 2022, Oct 11, 2022 through Oct 14, 2022. Venue: Palau de Congressos de Barcelona, FIRA Montju...

Neutral

Sachs Associates Ltd., 8th Annual Immuno-Oncolo...

2022-04-01 11:05:00

Sachs Associates Ltd., 8th Annual Immuno-Oncology Innovation Forum, May 24, 2022 through May 25, 2022.

Neutral

Sachs Associates Ltd., 22nd Annual Biotech in E...

2022-04-01 11:05:00

Sachs Associates Ltd., 22nd Annual Biotech in Europe Forum, Sep 21, 2022 through Sep 22, 2022.

Positive

BioNTech SE (NasdaqGS:BNTX) announces an Equity...

2022-03-31 07:09:00

BioNTech SE (NasdaqGS:BNTX) announces a share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of...

Positive

BioNTech SE authorizes a Buyback Plan.

2022-03-31 00:00:00

The Board of Directors of BioNTech SE has authorized a buyback plan on March 31, 2022.

Positive

BioNTech Seeks Acquisitions

2022-03-30 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Jens Holstein, Chief Financial Officer said, "To supplement our technologies and digi...

Neutral

Biontech Se Provides Revenue Guidance for the F...

2022-03-30 11:25:00

BioNTech SE provided revenue guidance for the financial year 2022. For the year, the company expects revenue of €13 billion - €17 billion.

Positive

BioNTech SE Proposes Special Cash Dividend

2022-03-30 10:00:00

BioNTech SE will proposed a special cash dividend of €2.00 per share at forthcoming 2022 Annual General Meeting.

Neutral

BioNTech SE - Analyst/Investor Day

2022-03-30 10:00:00

Capital Markets Day for analysts and investors

Positive

BioNTech SE's Board intends to launch an Equity...

2022-03-30 00:00:00

On March 30, 2022, the company announced that its Board of Directors will consider a proposal for share repurchase program. Under the program,...

Positive

Pfizer and BioNTech Receive Expanded U.S. Emerg...

2022-03-29 14:30:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccin...

Neutral

BioNTech SE Presents at 14th Kempen Life Scienc...

2022-03-29 06:52:00

BioNTech SE Presents at 14th Kempen Life Sciences Conference, Apr-20-2022 . Venue: Amsterdam, Netherlands.

Neutral

JPMorgan Chase & Co., JP Morgan 11th Annual Nap...

2022-03-27 23:13:00

JPMorgan Chase & Co., JP Morgan 11th Annual Napa Valley Biotech Forum, Apr 05, 2022. Venue: San Francisco, United States.

Neutral

BioNTech SE Presents at JP Morgan 11th Annual N...

2022-03-27 23:13:00

BioNTech SE Presents at JP Morgan 11th Annual Napa Valley Biotech Forum, Apr-06-2022 10:00 AM. Venue: San Francisco, United States.

Neutral

BioNTech SE Presents at Jefferies Biotech on th...

2022-03-27 23:13:00

BioNTech SE Presents at Jefferies Biotech on the Bay Summit, Apr-26-2022 . Venue: St. Regis, Bal Harbour, Florida, United States.

Neutral

Jefferies LLC, Jefferies Biotech on the Bay Sum...

2022-03-25 10:39:00

Jefferies LLC, Jefferies Biotech on the Bay Summit, Apr 26, 2022 through Apr 27, 2022. Venue: St. Regis, Bal Harbour, Florida, United States.

Neutral

BioNTech SE Presents at Bank of America 2022 He...

2022-03-22 05:03:00

BioNTech SE Presents at Bank of America 2022 Healthcare Conference, May-12-2022 08:00 AM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Veg...

Neutral

BioNTech SE Presents at Bernstein 38th Annual S...

2022-03-18 04:06:00

BioNTech SE Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-03-2022 09:00 AM. Venue: New York Hilton Midtown, 1335 Avenu...

Neutral

Sanford C. Bernstein & Co., LLC, Bernstein 38th...

2022-03-17 15:04:00

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022. Venue: New York Hilt...

Neutral

BioNTech SE Presents at The 13th Global Drug De...

2022-03-03 04:09:00

BioNTech SE Presents at The 13th Global Drug Delivery & Formulation Summit, Jun-27-2022 . Venue: Berlin, Germany. Speakers: Heinrich Haas, Vic...

Neutral

Bank of America Corporation, Bank of America 20...

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vega...

Neutral

Mark Allen Holdings Limited, the 13th Global Dr...

2022-02-16 09:24:00

Mark Allen Holdings Limited, The 13th Global Drug Delivery & Formulation Summit, Jun 27, 2022 through Jun 29, 2022. Venue: Berlin, Germany. F...

Neutral

Hanson Wade Limited, 5th European Neoantigen Su...

2022-02-16 04:05:00

Hanson Wade Limited, 5th European Neoantigen Summit 2022, Apr 26, 2022 through Apr 28, 2022. Venue: Amsterdam, Netherlands.

Neutral

BioNTech SE Presents at Eighth Annual Berenberg...

2022-02-15 17:59:00

BioNTech SE Presents at Eighth Annual Berenberg Conference USA 2022, May-23-2022 10:15 AM. Venue: Tarrytown House Estate, 49 East Sunnyside La...

Neutral

Jefferies LLC, 2022 Jefferies Global Healthcare...

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New Yor...

Positive

Pfizer and BioNTech Provides Update on Rolling ...

2022-02-11 18:30:00

Pfizer Inc. and BioNTech SE announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend...

Neutral

BioNTech SE to Report Q4, 2021 Results on Mar 30, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q4, 2021 results at 8:00 AM, US Eastern Standard Time on Mar 30, 2022

Neutral

BioNTech SE to Report Q1, 2022 Results on May 09, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q1, 2022 results at 8:00 AM, US Eastern Standard Time on May 09, 2022

Neutral

BioNTech SE to Report Q2, 2022 Results on Aug 08, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q2, 2022 results at 8:00 AM, US Eastern Standard Time on Aug 08, 2022

Neutral

BioNTech SE to Report Q3, 2022 Results on Nov 07, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q3, 2022 results at 8:00 AM, US Eastern Standard Time on Nov 07, 2022

Neutral

The Goldman Sachs Group, Inc., Goldman Sachs 43...

2022-02-08 07:31:00

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022. Venue: Terranea Reso...

Positive

Pfizer Inc. and BioNTech SE Initiate Rolling Su...

2022-02-01 21:27:00

Pfizer Inc. and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a...

Neutral

SwedenBIO Service AB, 2022 Nordic Life Science ...

2022-01-24 16:37:00

SwedenBIO Service AB, 2022 Nordic Life Science days, Sep 28, 2022 through Sep 29, 2022. Venue: Malmo, Sweden.

Neutral

BioNTech SE, Annual General Meeting, Jun 01, 2022

2022-01-24 00:05:00

BioNTech SE, Annual General Meeting, Jun 01, 2022, at 14:00 Central European Standard Time. Agenda: To consider the presentation of the adopte...

Neutral

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

2022-01-07 14:32:00

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

Neutral

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

2022-01-07 14:32:00

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

Neutral

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

2022-01-07 14:32:00

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

Neutral

BioNTech SE, Q3 2022 Earnings Call, Nov 07, 2022

2022-01-07 14:32:00

BioNTech SE, Q3 2022 Earnings Call, Nov 07, 2022

Negative

U.S. Food and Drug Administration Expands the E...

2022-01-03 21:39:00

On January 3, 2022, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Auth...

Positive

Pfizer and BioNTech Receive U.S. FDA Emergency ...

2022-01-03 14:45:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a...

Neutral

Joh. Berenberg, Gossler & Co. KG, The Goldman S...

2021-12-28 03:56:00

Joh. Berenberg, Gossler & Co. KG, The Goldman Sachs Group, Inc., Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep 19, 2022...

Neutral

Joh. Berenberg, Gossler & Co. KG, Eighth Annual...

2021-12-21 05:07:00

Joh. Berenberg, Gossler & Co. KG, Eighth Annual Berenberg Conference USA 2022, May 23, 2022 through May 25, 2022. Venue: Tarrytown House Estat...

Neutral

Pfizer and BioNTech to Provide European Union M...

2021-12-20 15:05:00

Pfizer Inc. and BioNTech SE announced an agreement has been reached with the European Commission (EC) and its member states to exercise an opt...

Positive

Pfizer Inc. and BioNTech SE Receive U.S. FDA Em...

2021-12-09 17:15:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a...

Neutral

BioNTech SE - Special Call

2021-12-08 12:15:00

To Provide an Update on Omicron Variant

Positive

Pfizer and BioNTech Provide Update on Omicron Variant

2021-12-08 11:54:00

Pfizer Inc. and BioNTech SE announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNT...

Positive

BioNTech SE and Ryvu Therapeutics S.A. Enters into Global Collaboration to Develop and Commercialize Immuno-Modulatory Small Molecule Candidates

2022-11-30 06:02:00

BioNTech SE and Ryvu Therapeutics S.A. announced that the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu’s STING agonist portfolio as standalone small molecules. The global collaboration will consist of two parts: BioNTech will receive a global, exclusive license to develop and commercialize Ryvu’s STING agonist portfolio as standalone small molecules, including as monotherapy and in therapeutic combinations. In addition, BioNTech and Ryvu will jointly undertake drug discovery and research projects to develop multiple small molecule programs directed at exclusive targets selected by BioNTech, primarily focused on immune modulation within oncology, with potential applications in other disease areas. BioNTech has the option to license global development and commercialization rights to these programs at the development candidate stage. Under the terms of the agreement, BioNTech will pay Ryvu an upfront fee of €20 million in exchange for certain rights to Ryvu’s STING agonist portfolio as standalone small molecules and for certain rights and options to license multiple small molecule programs as part of a multi-target research collaboration. In addition, BioNTech has committed to make an equity investment of €20 million. BioNTech will fund all discovery, research and development activities, including Ryvu’s discovery and research activities under the multi-target research collaboration. Ryvu will be eligible to receive success-based development, regulatory and commercialization milestone payments, as well as low single-digit royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

Neutral

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Provides Progress Update on the License Agreement between Fosun Pharmaceutical Industrial and BioNTech

2022-11-18 14:51:00

Shanghai Fosun Pharmaceutical (Group) Co. Ltd. announced that references are made to the overseas regulatory announcements of the Company dated 15 March 2020, 12 November 2020 and 12 July 2021, the announcements of the Company dated 10 November 2020, 16 December 2020, 25 January 2021 and 25 February 2021 in relation to, among other things, the entering into of the License Agreement and the Amendment No. 1 between Fosun Pharmaceutical Industrial, a subsidiary of the Company, and BioNTech, pursuant to which BioNTech granted Fosun Pharmaceutical Industrial a license to exclusively develop and commercialise its COVID-19 Vaccine developed based on BioNTech's proprietary mRNA technology platform targetingCOVID-19 in the Territory, and the authorisation regarding the use of the COVID-19 Vaccine (namely COMIRNATY BNT162b2) in Hong Kong, Macau and Taiwan region of China. The Board announced that, according to the press release of the Government of Hong Kong dated 18 November 2022, COMIRNATY Original/Omicron BA.4/BA.5-adapted bivalent vaccine has been authorised for emergency use in Hong Kong as a booster dose for individuals 12 years of age and older. Separately, the Bivalent Vaccine has also been granted a special import authorisation in Macau and obtained a special import approval in Taiwan region of China. The Bivalent Vaccine and the COMIRNATY BNT162b2 are both mRNA-based vaccine candidatesintroduced to the Territory under the License Agreement primarily for the prevention against COVID-19. Each dose of the Bivalent Vaccine contains 15-µg of mRNA encoding for the spike protein of the wild- type of SARS-CoV-2, which is present in the original mRNA COVID-19 vaccine, and 15-µg of mRNAencoding for the spike protein of the Omicron BA.4/BA.5 sublineage of SARS-CoV-2.

Positive

Pfizer and BioNTech Report New Data on Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Improved Immune Response Against Emerging Omicron Sublineages

2022-11-18 11:45:00

Pfizer Inc. and BioNTech SE announced results from an analysis examining the immune response induced by their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine [Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)] against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. These data, posted on the preprint server bioRxiv, indicate that the companies’ bivalent vaccine elicits a greater increase in neutralizing antibody titers than the companies’ original COVID-19 vaccine against these emerging Omicron sublineages. Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved protection against COVID-19 due to Omicron BA.4 and BA.5 sublineages as well as new sublineages that continue to increase in prevalence. Neutralization data were generated using a nonvalidated fluorescent focus reduction neutralization test (FFRNT) one month after administration of a 30-µg booster (fourth) dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine or the original COVID-19 vaccine in adults aged 55 and older (approximately 40/vaccine group). Sera were equally stratified by prior SARS-CoV-2 infection. Results showed the bivalent vaccine booster elicited a greater rise in neutralizing antibody titers for all tested Omicron sublineages compared to the original vaccine, regardless of prior SARS-CoV-2 infection status. Following a booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, neutralizing antibodies against BA.4.6 increased 11.1-fold (95% CI: 7.1, 17.3), while neutralizing antibodies against BA.2.75.2, BQ.1.1, and XBB.1 increased by 6.7-fold (95% CI: 4.4,10.2), 8.7-fold (95% CI: 5.7, 13.3), and 4.8-fold (95% CI: 3.3, 6.9), respectively. By comparison, the neutralizing antibody titers against BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 following a booster dose of the companies’ original COVID-19 vaccine increased 2.3-fold (95% CI: 1.9, 2.8), 2.1-fold (95% CI: 1.7, 2.5), 1.8-fold, (95% CI: 1.6, 2.2), and 1.5-fold (95% CI: 1.3, 1.8), respectively. Overall, the bivalent booster generated a greater increase in neutralizing antibodies against emerging Omicron sublineages than the original Pfizer-BioNTech COVID-19 vaccine. These results are similar to recent clinical data showing the Omicron BA.4/BA.5-adapted bivalent booster evokes a 13-fold increase in BA.4/BA.5 neutralizing titers from pre-booster levels in individuals 55 years and older, resulting in a 4-fold higher BA.4/BA.5 response than the companies’ original COVID-19 vaccine. A booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for ages 5 years and older and has been granted marketing authorization in the EU by the European Commission for ages 5 years and older. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Positive

Pfizer Inc. and BioNTech SE Advances Next-Generation COVID-19 Vaccine Strategy with Study Start of Candidate Aimed at Enhancing Breadth of T Cell Responses and Duration of Protection

2022-11-16 23:30:00

Pfizer Inc. and BioNTech SE announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicity of a next generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against COVID-19. This candidate, BNT162b4, is composed of a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are highly conserved across a broad range of SARS-CoV-2 variants and will be evaluated in combination with the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. These non-spike proteins have been chosen based on BioNTech's proprietary target prioritization platform and were designed into a vaccine candidate with the purpose of enhancing and broadening T cell immunity and potentially extending durability of protection against COVID-19. BNT162b4 will be evaluated in a U.S.-based study (NCT05541861) enrolling approximately 180 healthy individuals between 18 and 55 years of age, who have received at least three doses of an mRNA-based COVID-19 vaccine. The trial will explore different dose levels of BNT162b4 administered in combination with a 30-µg dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and will be compared to the administration of a 30-µg dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a booster. This study is part of the companies’ long-term and multi-pronged scientific strategy to generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19. As part of this approach the companies are developing multiple vaccine candidates with the aim of delivering a potential pan-SARS-CoV-2 vaccine. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) and BNT162b4 are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer and Biontech Receive Positive Chmp Opinion for Omicron Ba.4/Ba.5-Adapted Bivalent Covid-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union

2022-11-10 14:45:00

Pfizer Inc. and BioNTech SE announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5-µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized in the European Union (EU) as a booster dose for individuals aged 12 years and older. Today’s CHMP recommendation to include children 5 through 11 years of age was based on safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine in individuals 12 years and older, data from the initially approved 10-µg pediatric formulation of the companies’ original COVID-19 vaccine, manufacturing data from the companies’ pediatric formulation of the Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine. Recent clinical data from an ongoing Phase 2/3 trial of the companies’ BA.4/BA.5-adapted bivalent booster in adults 18 years of age and older demonstrated a strong immune response against the BA.4 and BA.5 sublineages, measured 30 days after immunization, with a safety and tolerability profile similar to the companies’ original COVID-19 vaccine. In addition to this trial and the already submitted data, a Phase 1/2/3 pediatric study is ongoing that evaluates different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. Data from both these trials will be shared with regulatory authorities around the world as soon as they become available. COMIRNATY® and its adapted vaccine variations (COMIRNATY® Original/Omicron BA.1 and COMIRNATY® Original/Omicron BA.4-5) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4-5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

BioNTech Seeks M&A Opportunities

2022-11-07 13:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for M&A opportunities. Ryan Richardson, Chief Strategy Officer said, "We will also continue to look for additive bolt-on BD and M&A opportunities that fit with our strategy. We remain as optimistic as ever in our ability to continue to create long-term value for patients, our shareholders and society".

Positive

BioNTech SE Se Revises Its Earnings Guidance for the Full Year 2022

2022-11-07 11:08:00

BioNTech SE revised its earnings guidance for the full year 2022. For the year, BioNTech updates its 2022 financial guidance, raising its COVID-19 vaccine revenue estimate to the upper end of the original range 16 billion to 17 billion(previously 13 billion to 17 billion).

Positive

Pfizer Inc. and BioNTech SE Announces Updated Clinical Data for Omicron Ba.4/Ba.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine

2022-11-04 10:47:00

Pfizer Inc. and BioNTech SE announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-month after a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies’ original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. These results reinforce the previously reported early clinical data measured 7 days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the original vaccine. For the analyses, sera were drawn before (baseline) and one month after administration of a 30-µg booster dose (fourth dose) of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine. A subset of individuals, evenly stratified between those who had evidence of prior SARS-CoV-2 infection and those who did not, was selected for ages 18 to 55 years (n=38) and older than 55 years and older (n=36). A comparator group of participants older than 55 years of age (n=40) who received a 30-µg booster dose (fourth dose) of the companies’ original COVID-19 vaccine as part of a prior study was randomly selected, while ensuring the same equal stratification. Participants receiving the bivalent vaccine had their prior booster dose approximately 10-11 months earlier, whereas those who received the original vaccine had their prior booster dose approximately 7 months earlier. Despite this difference, pre-booster antibody titers were similar for both. Among the overall study population who received the Omicron BA.4/BA.5-adapted bivalent vaccine, there was a substantially higher increase in Omicron BA.4/BA.5-neutralizing antibody titers compared to pre-booster levels. For individuals 18 to 55 years of age, the geometric mean titer (GMT) against Omicron BA.4/BA.5 was 606, representing a 9.5-fold rise (95% CI: 6.7, 13.6) from pre-booster levels. For individuals older than 55 years, the GMT was 896, representing a 13.2-fold rise (95% CI: 8.0, 21.6) from pre-booster levels. By contrast, participants over 55 years of age who received a 30-µg booster dose of the companies’ original COVID-19 vaccine had a lower neutralizing antibody response against Omicron BA.4/BA.5 measured one month post booster. For these participants, the GMT was 236, representing a 2.9-fold rise (95% CI: 2.1, 3.9). Therefore, the Omicron BA.4/BA.5 neutralizing antibody titers were approximately 4-fold higher for the bivalent vaccine compared to the companies’ original Covid-19 vaccine in individuals over 55 years of age. Further, when examining those with or without evidence of prior SARS-CoV-2 infection who received a booster dose of the bivalent vaccine, there was a significant increase in neutralizing antibodies against Omicron BA.4/BA.5 in both groups, which was greater in those without prior infection. These data highlight the potential benefit of the bivalent vaccine for all populations regardless of previous SARS-CoV-2 infection. The safety profile remains favorable for the bivalent vaccine and consistent with the original vaccine. Pfizer and BioNTech have shared these data with the U.S. Food and Drug Administration (FDA) and plan to share with the European Medicines Agency (EMA) and other global health authorities as soon as possible. A booster dose of the BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the FDA for ages 5 years and older and has also been granted marketing authorization in the EU by the European Commission following a positive opinion from the EMA for ages 12 years and older. An application for marketing authorization of the BA.4/BA.5 booster has been submitted to the EMA for children ages 5 through 11. Separately, Pfizer and BioNTech are continuing to monitor immunogenicity of the BA.4/BA.5 bivalent booster against emerging Omicron subvariants. The companies also initiated a Phase 1/2/3 trial in September 2022, in September 2022, to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine among children 6 months through 11 years of age. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®), which are based on BioNTech’s proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (WT/OMI BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

BioNTech SE Presents at TIDES Europe 2022, Nov-16-2022 through Nov-18-2022

2022-11-03 08:12:00

BioNTech SE Presents at TIDES Europe 2022, Nov-16-2022 through Nov-18-2022. Venue: Vienna, Austria. Presentation Date & Speakers: Nov-18-2022, Christoph Kroener, Director DNA Process Development & Cap Technology, Christoph Hubert Huber, Co-Founder & Member of Supervisory Board, Simon Klenk, Director RNA Analytics.

Positive

Pfizer and Biontech Receive Positive CHMP Opinion for Comirnaty® in Children 6 Months to Less Than 5 Years in the European Union

2022-10-19 15:45:00

Pfizer Inc. and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6 months through 4 years of age). The European Commission will review the CHMP recommendation and is expected to make a final decision soon. Today’s recommendation is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years. In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 was the predominant variant. Following the third dose in this age group, the companies’ original COVID-19 vaccine was found to be 73.2% (2-sided 95% CI: 43.8%, 87.6%) effective at preventing COVID-19, with a favorable safety profile similar to placebo. The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity. The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022. Submissions to other regulatory agencies around the world are ongoing. Pfizer and BioNTech are also in discussions with health authorities regarding a regulatory pathway for potential authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for use in children under 5 years of age. A Phase 1/2/3 pediatric study was initiated in September 2022 to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. COMIRNATY® and its adapted vaccine variations (COMIRNATY® Original/Omicron BA.1 and COMIRNATY® Original/Omicron BA.4-5) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

Informa plc, TIDES Europe 2022, Nov 16, 2022 through Nov 18, 2022

2022-10-18 07:11:00

Informa plc, TIDES Europe 2022, Nov 16, 2022 through Nov 18, 2022. Venue: Vienna, Austria.

Positive

Pfizer and BioNTech Announce Positive Early Data from Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older

2022-10-13 10:45:00

On October 13, 2022, Pfizer Inc. and BioNTech SE announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). Comparison of responses in individuals older than 55 years of age that received the bivalent vaccine or the original vaccine showed that a 30-µg booster dose of the Original Pfizer-BioNTech COVID-19 Vaccine (also referred to as BNT162b2 Wild Type), elicited more limited increases in the neutralizing antibody response against the Omicron BA.4/BA.5 variants. COVID-19 vaccine responses to date have reliably shown consistent trends across age groups and are further supported by these early data on the bivalent vaccine. Together, these data suggest a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better protection against the Omicron BA.4/BA.5 variants than the original vaccine for younger and older adults. The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine. Immunogenicity was evaluated using a SARS-CoV-2 live virus fluorescent focus reduction neutralization test (FFRNT) assay. Sera were collected 7 days post second booster dose from participants aged older than 55 (n=40) and compared to 7-day post sera from 40 participants older than 55 years of age that had received three prior doses of BNT162b2 encoding the wild-type spike-protein of SARS-CoV-2 and a second booster with BNT162b2 Wild-Type. Sera were also collected at 7 days post second booster dose from participants 18 to 55 years of age who received the Omicron BA.4/BA.5-adapted bivalent booster (n=40) to compare bivalent vaccine responses in younger and older adults. The time between third and fourth doses for the bivalent vaccine recipients was approximately 11 months compared to approximately 6 months for the original vaccine. Despite this difference, baseline neutralizing antibody response was generally similar across groups. Among the participants, samples were equally stratified at baseline in each group between those who had a prior or current history of SARS-CoV-2 and those with no prior or current history of SARS-CoV-2. Additional data measuring responses at one-month post-administration of the Omicron BA.4/BA.5 bivalent vaccine booster are expected in the coming weeks. These data will be used to support potential full licensure and global registration of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additionally, the companies have initiated a similar Phase 1/2/3 trial (NCT05543616) investigating the Omicron BA.4/BA.5-adapted bivalent vaccine among children 6 months through 11 years of age. A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for ages 12 years and older and has also been granted marketing authorization in the EU by the European Medicines Agency (EMA) for the same age group. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®), which are based on BioNTech’s proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (WT/OMI BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age

2022-10-12 14:16:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately. The authorization of the bivalent COVID-19 vaccine for children 5 through 11 years of age is supported by safety and immunogenicity data from Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 5 through 11 years of age are anticipated to start subject to and after the CDC endorses a potential recommendation. Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines. Pfizer and BioNTech have submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies’ marketing authorization in the European Union to include a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are planned for submission with regulatory authorities around the world in the coming weeks. A Phase 1/2/3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized underEmergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus.

Positive

Pfizer Canada ULC and BioNTech SE's Omicron Ba.4/Ba.5-Adapted Bivalent Covid-19 Vaccine Booster Receives Health Canada Authorization for Individuals 12 Years of Age and Older

2022-10-07 15:00:00

Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized COMIRNATY Original & Omicron BA.4/BA.5 as a 30-µg booster dose for individuals ages 12 years and older. An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children 5 through 11 years of age is also being planned for submission to Health Canada for review. The authorization of COMIRNATY Original & Omicron BA.4/BA.5 is based on clinical data from Pfizer and BioNTech's Monovalent ("original" vaccine), Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. A clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is currently underway. This data will be provided to the authorities in the coming months. Pfizer and BioNTech's bivalent COVID-19 vaccine contains 15-µg of mRNA encoding the spike protein of the wild-type of SARS-CoV-2, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 variants contain identical spike protein amino acid sequences, both can be targeted with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged. COMIRNATY and COMIRNATY Original & Omicron BA.4/BA.5, which are based on BioNTech's proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2- in Canada, the United States, the European Union, the United Kingdom and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

BioNTech SE and Australia’s State of Victoria Forms Strategic Partnership to Establish mRNA Research Center and Manufacturing Facility

2022-10-06 23:30:00

BioNTech SE announced that it has agreed a Letter of Intent with the State of Victoria in Australia on a strategic partnership between the State and BioNTech to collaborate on the research and development of potential mRNA-based vaccines and therapies. As part of the partnership, the parties will establish a research and innovation center in Melbourne to facilitate the transition of encouraging academic research into clinical development. BioNTech plans to set up a clinical scale end-to-end mRNA manufacturing facility based on its BioNTainer solution in Melbourne with the aim of supporting the design, manufacture and clinical testing of product candidates. Part of BioNTech’s global network, the facility is expected to attract interest from researchers locally, regionally and globally. As part of this collaboration, the State of Victoria and BioNTech will establish a research and innovation center, directed in partnership with the State, with the aim to support Australia’s mRNA ecosystem by curating projects and to determine their potential transition into preclinical and clinical development, supported by BioNTech’s advice and know-how. The partnership will also include the research and development of experimental therapies including mRNA-based product candidates for indications with high unmet medical need, for instance in oncology. BioNTech will support the R&D efforts on a project-by-project basis with the Company’s expertise in mRNA research and clinical development of potential new products. In addition to driving innovative translational research, BioNTech will also support local delivery by developing and commissioning an end-to-end clinical-scale manufacturing facility for mRNA-based medicines and product candidates in Melbourne, Victoria. BioNTech has developed the BioNTainer, a mobile modular manufacturing unit requiring limited space for operation, allowing for timely and flexible local production of different mRNA-based constructs and products across a variety of indications, and expects to create hundreds of jobs during construction and operation in Melbourne. BioNTech intends to further strengthen the clinical development capabilities in Australia and includes sites that aim to accelerate the development of its clinical stage oncology pipeline which currently encompasses a total of 18 product candidates in 23 ongoing clinical trials. BioNTech is currently recruiting cancer patients for two Phase 2 mRNA-based product candidates in Australia – BNT111 and BNT113 – and plans to further expand its clinical development, including for the Company’s candidate BNT211, which combines a CAR-T cell therapy approach with an mRNA vaccine.

Positive

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

2022-09-26 10:45:00

Pfizer Inc. and BioNTech SE announced they have completeda submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision. An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days. The companies have also initiated a Phase 1/2/3 study NCT05543616 [1] (C4591048) to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. This pediatric study is consistent with regulatory guidance and follows aprevious [2] Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offersa high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. About the Study: The Phase 1/2/3 pediatric clinical study will have four substudies examining different bivalent vaccine dosing regimens, dose levels and ages, including: Substudy A (Ages 6 through 23 months who are COVID-19 vaccine-naïve): Phase 1 dose-finding study will evaluate 3-µg, 6-µg, and 10-µg dose levels of the bivalent vaccine. Based on Phase 1, Participants in the Phase 2/3 will receive the selected dose as a three-dose primary series, followed by a booster dose. Substudy B (Ages 6 months through 4 years who had previously received2-3 doses of original COVID-19 vaccine): Those who have received two doses of the original COVID-19 vaccine prior to enrollment will receive both athird and fourth3-µg dose of the bivalent vaccine. Those who have previously received three doses of the original vaccine will receivea3-µg booster (fourth) dose of the bivalent vaccine. Substudy C (Ages 6 months through 4 years who had previously received3 doses of original COVID-19 vaccine): Phase 1 dose-finding study will evaluate 6-µg and 10-µg dose levels of the bivalent vaccine for afourth dose. Based on Phase 1, Phase 2/3 will receive the selected dose as afourth dose. Substudy D (Ages 5 through 11 years who had previously received2-3 doses of original COVID-19 vaccine): Participants will receive the bivalent vaccine as either athird or fourth 10-µg booster dose.

Neutral

BioNTech SE Presents at 22nd Annual Biotech in Europe Forum, Sep-21-2022

2022-09-16 19:08:00

BioNTech SE Presents at 22nd Annual Biotech in Europe Forum, Sep-21-2022 .

Positive

Pfizer Inc. and BioNTech SE Receive Positive Chmp Opinion for Conversion of Comirnaty® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

2022-09-16 12:00:00

Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside modified)] to standard (also referred to as “full”) Marketing Authorization (MA) for all authorized indications and formulations. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. The conversion, if approved by the EC, applies to all existing COMIRNATY indications and formulations authorized in the EU, including Pfizer and BioNTech’s bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older in the EU. In a separate action, the CHMP also recommended approval for COMIRNATY as a 10-µg booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age. COMIRNATY 10-µg was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11 years of age. Today’s recommendation is based on Phase 2/3 clinical data from participants 5 through 11 years of age who received a 10-µg booster dose of COMIRNATY approximately 6 months after completing the two-dose primary series. The third dose was well tolerated with a favorable safety profile, and generated neutralizing antibodies against both Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis. The EC will review the CHMP opinion and if MA is granted, the decision will be immediately applicable to all 27 European Union member states. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. COMIRNATY® ? (the Pfizer-BioNTech COVID-19 vaccine) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose. In addition, the cMA has been expanded to include a booster dose (third dose) at least 3 months after the second dose in individuals 12 years of age and older. A third primary course dose may be administered at least 28 days after the second dose to people aged 5 years and older with a severely weakened immune system. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available. In addition, COMIRNATY has also been granted standard MA for two adapted vaccines: COMIRNATY Original/Omicron BA.1, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.1 subvariant of SARS-CoV-2; and COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2. COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may be administered as a booster in people aged 12 years and older who have received at least a primary vaccination course against COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 and the last prior dose of a COVID-19 vaccine.

Neutral

BioNTech SE Presents at Longwood Healthcare Leaders Fall Webconference, Sep-21-2022 08:50 AM

2022-09-15 15:45:00

BioNTech SE Presents at Longwood Healthcare Leaders Fall Webconference, Sep-21-2022 08:50 AM. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Positive

Pfizer and BioNTech SE Receive Positive CHMP Opinion for Omicron Ba.4/Ba.5-Adapted Bivalent Covid-19 Vaccine Booster in European Union

2022-09-12 15:20:00

Pfizer Inc. and BioNTech SE announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s Committee for Medicinal Products for Human Use for individuals ages 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.4/BA.5-adapted bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged. recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities to advance bivalent vaccine candidates, with the goal of making an Omicron-adapted vaccine available to European Union member states as soon as possible. The CHMP recommendation concerning the Omicron BA.4/BA.5 bivalent COVID-19 vaccine is based on data from Pfizer’s and BioNTech’s Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the ompanies’ current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus, while retaining a favorable safety profile. If an authorization is granted, the Pfizer-BioNTech bivalent micron BA.4/BA.5 COVID-19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination campaigns. Local supply may vary based on individual country government requests. In early September, Pfizer and BioNTech were granted aconditional marketing authorization for an Omicron BA.1-adapted bivalent COVID-19 vaccine in the EU. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was also authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022. The companies are also planning to file the data with other regulatory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an application for an Omicron-adapted bivalent vaccine in children younger than 12 years of age. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 in theUnited States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is FDA-authorized underEmergency Use Authorization for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. AUTHORIZED USES Primary Series athird primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise Pfizer-BioNTech COVID-19 Vaccine INDICATION Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide: AUTHORIZED USES Primary Series a3-dose primary series to individuals 6 months through 4 years of age a2-dose primary series to individuals 5 years through 11 years of age athird primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise Booster a single booster dose to individuals 5 through 11 years of age who have completeda primary series with Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization to prevent Coronavirus Disease 2019 in: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) individuals 12 years of age and older (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Neutral

BioNTech SE Presents at European Society for Medical Oncology (ESMO) Annual Congress 2022, Sep-09-2022

2022-09-09 14:30:00

BioNTech SE Presents at European Society for Medical Oncology (ESMO) Annual Congress 2022, Sep-09-2022 . Venue: Paris Expo Porte de Versailles, 1 Pl. de la Porte de Versailles, France, France.

Positive

Biontech Presents Encouraging Phase 1/2 Follow-Up Data for Car-T Candidate Bnt211 in Hard-To-Treat Solid Tumors At ESMO

2022-09-09 14:30:00

BioNTech SE presented positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany. BNT211 is a novel therapeutic approach which comprises a synergistic combination of two of BioNTech’s proprietary platforms. The candidate combines an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate recently received Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the third- or later-line treatment of testicular germ cell tumors. The designation was granted based on the encouraging initial data particularly in patients with testicular cancer which is the most common type of germ cell tumors. BioNTech presented data from the ongoing Phase 1/2 trial (NCT04503278; 2019-004323-20) at the American Association for Cancer Research (AACR) annual meeting in April 2022 and at the annual meeting of the Association for Cancer Immunotherapy (CIMT) in May 2022.

Neutral

Longwood, Longwood Healthcare Leaders Fall Webconference, Sep 21, 2022 through Sep 22, 2022

2022-09-08 20:05:00

Longwood, Longwood Healthcare Leaders Fall Webconference, Sep 21, 2022 through Sep 22, 2022.

Positive

Pfizer Inc. and BioNTech SE Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union

2022-09-01 13:45:00

Pfizer Inc. and BioNTech SE announced a 30 µg booster dose of their Omicron BA.1- Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.1-adapted bivalent vaccine contains 15 µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15 µg of mRNA encoding the spike protein of the Omicron BA.1 subvariant. Apart from the addition of the mRNA sequence of the BA.1 spike protein, all other components of the vaccine remain unchanged. The CHMP recommendation is based on previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of participants 56 years of age and older who received a 30-µg booster dose of the Omicron BA.1-adapted bivalent vaccine. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine (n=178) elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine (n=163) as demonstrated by an approximately 9-fold improvement in neutralizing titers. In additional analyses of a SARS-CoV-2 live virus neutralization assay tested on sera from participants in this trial, neutralization titers improved by approximately 4-fold for BA.4/BA.5 (n=100). The BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile. If an authorization is granted, COMIRNATY® Original/Omicron BA.1 doses will be available within the coming days to all 27 EU member states supporting the start of the European vaccination campaigns. Local supply may vary based on individual country government requests. The companies have also filed an application to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine to allow for flexible vaccination strategies. This application is currently under review. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older

2022-08-31 14:12:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the FDA in early October. The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.  The Omicron BA.4 and BA.5 subvariants together are the prevalent variants of concern in the U.S., prompting the FDA to instruct manufacturers to develop a variant-adapted vaccine that also addresses the spike-protein of the Omicron BA.4/BA.5 subvariants. Pfizer and BioNTech’s bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike -protein of SARS-CoV-2, which is present in the original Pfizer-BioNTech COVID-19 vaccine and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical spike protein amino acid sequences, both can be targeted at once with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.  The authorization of the bivalent COVID-19 vaccine is based on clinical data from Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 12 years of age and older are anticipated to start subject to and after the Centers for Disease Control and Prevention (CDC) endorse a potential recommendation by the Advisory Committee on Immunization Practices (ACIP). Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines. Pfizer and BioNTech have submitted data on their Omicron-adapted bivalent vaccines to the European Medicines Agency (EMA) and other regulatory authorities around the world. As a result of this authorization, Pfizer and BioNTech will file a new supplemental Biologics License Application (sBLA) for the Omicron-BA.4/BA.5 bivalent booster vaccine and therefore, withdraw the sBLA for a booster dose of the original Pfizer-BioNTech COVID-19 monovalent vaccine for individuals 16 and older. The original Pfizer-BioNTech COVID-19 vaccine will remain available as a booster dose for children 5 through 11 years of age and as a primary series for those 6 months of age and older.

Positive

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

2022-08-26 13:52:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. This application for a variation of the conditional marketing authorization (cMA) follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing Omicron-adapted bivalent vaccines. The bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike-protein of SARS-CoV-2, which is present in COMIRNATY (the original Pfizer-BioNTech COVID-19 Vaccine) and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 variants. With the exception of the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, all other components of the vaccine remain unchanged. Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. In addition to the pre-clinical, quality and manufacturing data for the Omicron BA.4/BA.5 adapted bivalent vaccine, the submission is supported by safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine, which combines 15-µg of mRNA encoding the wild type spike protein of SARS-CoV-2 with 15-µg of mRNA encoding the spike protein of the Omicron BA.1 variant. The companies have also provided safety data from clinical trials evaluating multiple variant-adapted vaccine candidates based on previous variants of concern (e.g., Alpha, Beta and Delta variants). Pfizer and BioNTech also filed an application with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July which is currently under review by the Agency. Both the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September, pending regulatory approval. Local supply may vary based on individual country government requests. On August 22, the companies also completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer Inc. and BioNTech SE Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

2022-08-26 13:45:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. This application for a variation of the conditional marketing authorization (cMA) follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing Omicron-adapted bivalent vaccines. The bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike-protein of SARS-CoV-2, which is present in COMIRNATY® (the original Pfizer-BioNTech COVID-19 Vaccine) and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 variants. With the exception of the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, all other components of the vaccine remain unchanged. Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. In addition to the pre-clinical, quality and manufacturing data for the Omicron BA.4/BA.5 adapted bivalent vaccine, the submission is supported by safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine, which combines 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 with 15-µg of mRNA encoding the spike protein of the Omicron BA.1 variant. The companies have also provided safety data from clinical trials evaluating multiple variant-adapted vaccine candidates based on previous variants of concern (e.g., Alpha, Beta and Delta variants). Pfizer and BioNTech also filed an application with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July which is currently under review by the Agency. Both the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September, pending regulatory approval. Local supply may vary based on individual country government requests. On August 22, the companies also completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. COMIRNATY® ? (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorization (CMA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose. In addition, the CMA has been expanded to include a booster dose (third dose) at least 3 months after the second dose in individuals 12 years of age and older. A third primary course dose may be administered at least 28 days after the second dose to people aged 5 years and older with a severely weakened immune system. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

Neutral

BioNTech SE Presents at 5th HKEX Biotech Summit 2022, Sep-01-2022 10:20 AM

2022-08-23 13:20:00

BioNTech SE Presents at 5th HKEX Biotech Summit 2022, Sep-01-2022 10:20 AM. Speakers: Ugur Sahin, Co-Founder, CEO & Chair of the Management Board.

Neutral

Hong Kong Exchanges and Clearing Limited, 5th HKEX Biotech Summit 2022, Sep 01, 2022

2022-08-23 11:30:00

Hong Kong Exchanges and Clearing Limited, 5th HKEX Biotech Summit 2022, Sep 01, 2022.

Positive

Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months Through 4 Years of Age

2022-08-23 10:45:00

Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022. Emergency Use Authorization (EUA) of this vaccine was granted by the U.S. Food and Drug Administration (FDA) for this age group on June 17, 2022, and an application for conditional marketing authorization in this age group is under review by the European Medicines Agency (EMA).Participants in the study received either the Pfizer-BioNTech COVID-19 Vaccine (3-µg) as a three-dose series or placebo (2:1 randomization). Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI:43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection. This analysis was based on 13 cases in the Pfizer-BioNTech COVID-19 Vaccine group (n=794) and 21 cases in the placebo group (n=351), diagnosed from March to June 2022. The study protocol specified that this formal efficacy analysis should be performed when at least 21 total symptomatic COVID-19 cases were identified, each at least seven days after the third dose. Consistent with the time period when the cases occurred, sequencing of viralRNA from illness visit nasal swabs indicated that observed cases were primarily caused by Omicron BA.2. Omicron BA.4 and BA.5 strains were emerging during the period of the study, with only a few cases accrued and efficacy results against these strains were inconclusive. Consistent with the approach in adults, the company is working with the FDA to prepare an EUA application for an Omicron BA.4/BA.5-adapted bivalent vaccine in children6 months through 11 years of age. Among children ages 6 through 23 months, the vaccine was 75.8% (2-sided 95% CI: 9.7%, 94.7%) effective at preventing COVID-19, based on 4 cases in the vaccine group (n=296) and 8 cases in the placebo group (n=147),after a median of 1.9 months (range: 0.0, 4.9) follow-up after the third dose. For children ages 2 through 4years of age, the vaccine was 71.8 (2-sided 95% CI: 28.6%, 89.4%) effective at preventing COVID-19, based on 9cases in the vaccine group (n=498) and 13 cases in the placebo group (n=204), after a median of 2.4 months(range: 0.0, 4.9) follow-up after the third dose. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine continue to be well-tolerated in this age group. The majority of adverse events observed in this age group have been mild or moderate, with a safety profile similar to placebo. On July 8 [5], Pfizer and BioNTech submitted safety and immunogenicity data to the EMA requesting an update to the Conditional Marketing Authorization (CMA) in the European Union (EU) to include children ages 6 months through 4 years. The companies plan to submit the updated efficacy data to the FDA, EMA and other regulatory agencies around the world in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the EU, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.U.S. Indication & Authorized Use: Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series A 3-dose primary series to individuals 6 months through 4 years of age, a 2-dose primary series to individuals 5 years through 11 years of age, a 2-dose primary series to individuals 12 years of age and older, a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise Booster Series, a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine: a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) · a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series · a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine · a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine. COMIRNATY® INDICATIONCOMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. COMIRNATY® is administered as a 2-dose primary series. COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart. COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide: Primary Series: a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Booster Dose: a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®, a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine, a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Positive

Pfizer and Biontech Submits Application to U.S. FDA for Emergency Use Authorization of Omicron Ba.4/Ba.5-Adapted Bivalent Covid-19 Vaccine

2022-08-22 14:30:00

Pfizer Inc. and BioNTech SE announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. Preclinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month. The companies previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. The Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile. Following guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA), Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

BioNTech SE Presents at World Vaccine Congress Europe 2022, Oct-11-2022 through Oct-14-2022

2022-08-18 04:38:00

BioNTech SE Presents at World Vaccine Congress Europe 2022, Oct-11-2022 through Oct-14-2022. Venue: Palau de Congressos de Barcelona, FIRA Montjuic, Barcelona, Spain. Presentation Date & Speakers: Oct-11-2022, Ruben Rizzi, Vice President of Global Regulatory Affairs. Oct-13-2022, Ruben Rizzi, Vice President of Global Regulatory Affairs, Shanti Pather, Senior Global Medical Affairs Director, Vaccines. Oct-14-2022, Shanti Pather, Senior Global Medical Affairs Director, Vaccines.

Neutral

BioNTech SE Presents at Onco Cell Therapy Summit Europe 2022, Nov-02-2022

2022-08-12 13:56:00

BioNTech SE Presents at Onco Cell Therapy Summit Europe 2022, Nov-02-2022 . Venue: Amsterdam, Netherlands. Speakers: Benjamin Rengstl, Director, Clinical Development & Director, Immunoreceptor Therapy.

Neutral

Kisaco Research, Onco Cell Therapy Summit Europe 2022, Nov 02, 2022 through Nov 03, 2022

2022-08-12 11:30:00

Kisaco Research, Onco Cell Therapy Summit Europe 2022, Nov 02, 2022 through Nov 03, 2022. Venue: Amsterdam, Netherlands.

Neutral

BioNTech SE Presents at Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep-20-2022 04:30 PM

2022-08-12 10:45:00

BioNTech SE Presents at Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep-20-2022 04:30 PM. Venue: Infinity Munich Hotel, Andreas-Danzer-Weg 1, 85716 Unterschleißheim, Munningen, Germany. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Positive

BioNTech Seeks Acquisitions

2022-08-08 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Ryan Richardson,Chief Strategy Officer said, "So we are looking at a wide range of opportunities. But for the most part, Matt, we're looking really at bolt-on acquisitions and/or strategic partnerships. Our focus is going to continue to be on organic R&D and scaling that up over the coming years. And as we get into more registrational trials with our own pipeline, we think we'll have a better ability, say, over the next 24 months or so, to be able to deploy capital into those pivotal trials that could deliver products for launches over the next 3 to 5 years, as Ugur laid out".

Neutral

BioNTech Reiterates Revenue Guidance for the Full Year 2022

2022-08-08 10:00:00

BioNTech Reiterates revenue guidance for the full year 2022. The company estimated BioNTech COVID-19 vaccine revenues for the full 2022 financial year of €13 billion - €17 billion.

Neutral

Tranche Update on BioNTech SE (NasdaqGS:BNTX)'s Equity Buyback Plan announced on March 31, 2022.

2022-08-08 07:18:00

From April 1, 2022 to June 30, 2022, the company has repurchased 2,078,207 shares, representing 0.86% for $302.69 million. With this, the company has completed the repurchase of 2,078,207 shares, representing 0.86% for $302.69 million under the buyback announced on March 31, 2022.

Positive

Genmab A/S and BioNTech SE Expand Global Strategic Collaboration to Develop and Commercialize Novel Immunotherapy Candidates

2022-08-05 10:45:00

Genmab A/S and BioNTech SE announced an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under the expansion, Genmab and BioNTech will jointly work to research, develop, and commercialize novel monospecific antibody candidates for various cancer indications. Since 2015, the companies have been working on the joint development of bispecific cancer antibodies aimed at improving immunotherapy options for cancer patients. Under the expanded collaboration, the companies will jointly develop and commercialize, subject to regulatory approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform. The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022. GEN1053/BNT313 is a CD27 antibody based on the HexaBody technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. Under the terms of the agreement, the companies will equally share the development costs and potential future profit deriving from GEN1053/BNT313. The companies currently have two jointly developed investigational medicines in clinical testing since 2019, fusing BioNTech’s proprietary immunomodulatory antibodies and Genmab’s DuoBody technology platform: GEN1046/BNT311 (DuoBody-PD-L1x4-1BB) is being evaluated in phase 1/2 clinical trials for the treatment of advanced solid tumors (NCT04937153, NCT03917381), and in a phase 2 study of patients with non-small cell lung cancer (NSCLC) (NCT05117242). GEN1042/BNT312 (DuoBody-CD40x4-1BB) is being evaluated for the treatment of patients with metastatic or locally advanced solid tumors in a phase 1/2 study (NCT04083599).

Positive

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy with Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

2022-07-27 10:45:00

Pfizer Inc. and BioNTech SE announced that the companies have initiated a randomized, active-controlled, observer-blind Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19. This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19. BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days prior to their first study visit. Participants will be stratified by the number of months since their last dose of COVID-19 vaccine received prior to entering the study (three to six months or more than six months). The study does not include a placebo (injection with no active ingredient). The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series: A 3-dose primary series to individuals 6 months through 4 years of age, a 2-dose primary series to individuals 5 years of age and older, and a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise. Booster Series: a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine, a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA), a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine, and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine. COMIRNATY® INDICATION: COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. COMIRNATY® is administered as a 2-dose primary series. COMIRNATY® AUTHORIZED USES: COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide: Primary Series: a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Booster Dose: a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®, a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series, a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine, and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Positive

Pfizer Inc. and BioNTech SE Submits Variation to the European Medicines Agency

2022-07-11 10:06:00

Pfizer Inc. and BioNTech SE submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children 6 months to less than 5 years of age (also referred to as 6 months through 4 years of age) with the 3- g dose of COMIRNATY (COVID-19 vaccine, mRNA) as a three dose series. The 3- g dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data. The submission included data from a Phase 2 3 randomized, controlled trial that included 4,526 children 6 monthsto less than 5 years of age. In the trial, children received the third 3- g dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months to less than 5 years were generally lower than in children 5 to less than 12 years of age. Pfizer and BioNTech submitted the same data to the U.S. Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3- g dose primary series in this age group in June 2022 The companies also plan to submit these data to other regulatory agencies around the world. COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age

2022-07-08 21:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) approved the companies' supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the U.S. under emergency use authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series. The approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30- g dose) elicited SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. In the trial, a two-dose primary series of the vaccine (30- g dose) was also 100% effective (95% confidence interval CI, 87.5, 100.0) in preventing COVID-19, measured between a week and more than four months after the second dose. During this time, all 30 cases of confirmed symptomatic COVID-19 were in the placebo group (n 1,109) and no cases were in the COMIRNATY group (n 1,119). The only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha as the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges. No cases of severe disease occurred in either the COMIRNATY or placebo group. The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow-up data after the second dose. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world. COMIRNATY is now the only COVID-19 vaccine approved by the FDA as a two-dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer-term follow-up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12-15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the U.S. FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA. COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Negative

CureVac Files Patent Infringement Lawsuit in Germany Against BioNTech

2022-07-05 11:00:00

CureVac N.V. announced that it has moved to assert its intellectual property rights, accumulated over more than two decades of pioneering work in mRNA technology, which contributed to COVID-19 vaccine development. CureVac has filed a lawsuit in the German Regional Court in D-sseldorf against BioNTech SE and two of its subsidiaries, seeking fair compensation for infringement of a portfolio of CureVac's intellectual property rights, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, utilized in the manufacture and sale of Comirnaty-, BioNTech and Pfizer's mRNA COVID-19 vaccine. CureVac does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty- by BioNTech and its partner Pfizer. The CureVac intellectual property portfolio protects multiple inventions that are considered essential to the design and development of BioNTech's SARS CoV-2 mRNA vaccine, among others. These relate to the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expression, as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines.

Neutral

BioNTech SE Presents at 2022 Nordic Life Science days, Sep-28-2022 04:00 PM

2022-06-30 08:51:00

BioNTech SE Presents at 2022 Nordic Life Science days, Sep-28-2022 04:00 PM. Venue: Malmo, Sweden. Speakers: Holger Kissel, Vice President Business Alliances.

Neutral

Pfizer Inc. and BioNTech SE Announces New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine

2022-06-29 20:45:00

Pfizer Inc. and BioNTech SE announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year. The U.S. government will pay the companies $3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.

Positive

Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

2022-06-25 14:00:00

Pfizer Inc. and BioNTech SE announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine. The robust immune response was seen across two investigational dose levels, 30 µg and 60 µg. The Omicron adapted vaccine candidates (30 µg and 60 µg) studied in the Phase 2/3 trial in 1,234 participants 56 years of age and older elicited substantially higher neutralizing antibody responses against Omicron BA.1 when compared to the companies’ current COVID-19 vaccine. The pre-specified criterion for superiority was measured by the ratio of neutralizing geometric mean titers (GMR) with the lower bound of the 95% confidence interval >1. The geometric mean ratios (GMRs) for the monovalent 30 µg and 60 µg vaccines compared to the current COVID-19 vaccine were 2.23 (95% CI: 1.65, 3.00) and 3.15 (95% CI: 2.38, 4.16), respectively. The GMRs for the bivalent 30 µg and 60 µg vaccines compared to the current COVID-19 vaccine were 1.56 (95% CI: 1.17, 2.08) and 1.97 (95% CI: 1.45, 2.68), respectively. The monovalent Omicron-adapted vaccine 30 µg and 60 µg achieved a lower bound 95% confidence interval for GMR of >1.5, consistent with the regulatory requirement of super superiority. Demonstration of superiority against Omicron and safety are regulatory requirements for potential emergency use authorization of a variant-adapted vaccine. One month after administration, a booster dose of the Omicron-adapted monovalent candidates (30 µg and 60 µg) increased neutralizing geometric mean titers (GMT) against Omicron BA.1 13.5 and 19.6-fold above pre-booster dose levels, while a booster dose of the Omicron-adapted bivalent candidates conferred a 9.1 and 10.9-fold increase in neutralizing GMTs against Omicron BA.1. Both Omicron-adapted vaccine candidates were well-tolerated in participants who received one or the other Omicron-adapted vaccine. In a SARS-CoV-2 live virus neutralization assay tested on sera from participants over 56 years of age and older, sera efficiently neutralized BA.4/BA.5 with titers approximately 3-fold lower than BA.1. Pfizer and BioNTech will continue to collect additional study data on Omicron BA.4/BA.5 over the coming weeks. These results are being shared with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in advance of upcoming discussions with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28 and with the International Coalition of Medicines Regulatory Authorities (ICMRA) on June 30. The companies have also submitted additional data from their ongoing COVID-19 booster studies, including data on an additional dose of their current COVID-19 vaccine and Beta candidate, to further demonstrate the flexibility and potential benefit of mRNA-based vaccines. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series A 3-dose primary series to individuals 6 months through 4 years of age a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise Booster Series a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine Primary Series a 2-dose primary series to individuals 12 through 15 years of age a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise Booster Dose a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine Emergency Use Authorization Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Positive

BioNTech SE Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer

2022-06-23 15:00:00

BioNTech SE announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech’s fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company’s proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate is currently being investigated in an ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors. The designation is based on positive preliminary Phase 1/2 data from the ongoing study that was presented at the AACR Annual Meeting in April 2022. The results demonstrated that treatment with CLDN6 CAR-T alone or in combination with CARVac was well tolerated and showed encouraging signs of anti-tumor activity in testicular cancer patients at the first evaluated dose levels. In the study all six patients with heavily pretreated testicular cancer eligible for efficacy analysis showed clinical benefits highlighting the potential of this novel approach. One patient achieved a complete response 18 weeks after infusion. Three patients achieved a partial response and showed deepening and durability of responses (one of them in the lowest CAR-T dose level cohort in combination with CARVac). One patient had stable disease with shrinkage of target lesions. The PRIME scheme is a regulatory mechanism introduced by the EMA that provides early and proactive support to developers of promising medicines, to optimize development plans and speed up evaluations so these medicines can reach patients faster. The goal is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need. Aiming to harness the power of cell therapies for solid cancers and to overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech`s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. The CARVac is based on BioNTech’s backbone-optimized uridine mRNA (uRNA)-lipoplex technology which through its inherent adjuvant function enables a potent T cell stimulation to improve persistence and functionality of the adoptively transferred CAR-T cells, thus enabling and maintaining a therapeutic effect even at low CAR-T doses. BNT211 is an investigational CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered by BioNTech founders and expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Positive

BioNTech Starts Construction of First mRNA Vaccine Manufacturing Facility in Africa

2022-06-23 10:00:00

BioNTech SE has reached the next milestone in the establishment of scalable mRNA vaccine production in Africa on its planned schedule. Today, BioNTech welcomed its African partners for the first time on the African continent as construction works for the initial African mRNA manufacturing facility began in Kigali, Rwanda, with a target for the first set of manufacturing BioNTainers to be delivered to the site by the end of 2022. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries. The initial site will become a node in a decentralized and robust African end-to-end manufacturing network. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union. The Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers (one for the production of mRNA, and one for the production of the formulated bulk drug product). The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities. The estimated initial annual capacity of e. g. the Pfizer-BioNTech COVID-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after their installation.

Neutral

BioNTech SE - Special Call

2022-06-20 15:30:00

To provide an update on BioNTech's clinical progress across its pipeline and provide a deep-dive on scientific and technology innovation from its proprietary research engine

Positive

Pfizer and BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

2022-06-17 13:24:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data. The EUA is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age. In the trial, children received the third3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following athird dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) one month after the third dose was 1,535.2 (95% CI, 1,388.2, 1,697.8) in children 2 through 4 years of age and 1,406.5 (95% CI, 1,211.3, 1,633.1) in infants 6 through 23 months. The antibody responses in both age groups were comparable to those recorded in people 16 to 25 years of age immunized with two 30-µg doses and met the pre-specified success criteria to declare non-inferiority. Demonstration of noninferiority and safety were the regulatory requirements for potential authorization of the Pfizer-BioNTech COVID-19 Vaccine in this age group. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine demonstrated a favorable safety and tolerability profile comparable to placebo. No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months through 4 years were generally lower than in children 5 through 11 years. In the 6 through 23 months age group, 30.3% of participants reported adverse events in the Pfizer-BioNTech COVID-19 Vaccine group, and 27.3% of participants reported adverse events in the placebo group. Similarly, 18.8% and 18.9% of participants who received the Pfizer-BioNTech COVID-19 Vaccine or placebo respectively reported adverse events in the 2 through 4-year age group. Reactogenicity events were mostly mild to moderate and short lived for both age groups with systemic events comparable to placebo. Reactions were comparable after dose 1, 2 and 3. The clinical trial results were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 15, who unanimously recommended authorization. The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet June 17 and June 18 to discuss a potential recommendation for the use and rollout of the vaccine to children 6 months through 4 years of age. Vaccinations for children 6 months through 4 years of age are anticipated to start subject to and after the CDC endorses the ACIP recommendation. Pfizer and BioNTech will begin shipping 3-µg pediatric doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines. The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency in early July. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

BioNTech SE - Special Call

2022-06-09 12:31:00

To provide an Update on Manufacturing and Development Plans of mRNA Vaccines in Africa

Neutral

BioNTech SE Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM

2022-06-07 20:15:00

BioNTech SE Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM. Venue: Marriott Marquis, New York City, New York, United States.

Positive

BioNTech SE Announces Positive Phase 1 Data from MRNA-Based Individualized Neoantigen Specific Immunotherapy in Patients with Resected Pancreatic Cancer Presented At ASCO

2022-06-05 16:30:00

BioNTech SE announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC). Feasibility of the process of profiling each patient’s tumor to inform individualized vaccine design and on-demand manufacturing of iNeST in a clinically relevant timeframe was confirmed. The preliminary results showed a favorable safety profile as well as encouraging signs of clinical activity. The data have been presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting 2022 by Vinod Balachandran, M.D., at Memorial Sloan Kettering Cancer Center. Autogene cevumeran is the lead candidate from BioNTech’s iNeST platform, which is jointly developed together with Genentech, a member of the Roche Group, in multiple solid tumor indications. The data presented at the ASCO Annual Meeting include a total of 19 patients who underwent surgery and received atezolizumab. 16 out of these 19 patients (84%) received autogene cevumeran at 9.4 weeks (median; 95% CI 9–10) after surgery. The preliminary data readout from these 16 vaccinated patients revealed that autogene cevumeran in combination with atezolizumab was well-tolerated. Only 1 of 16 patients (6%) developed a vaccine-related Grade 3 fever and hypertension, no other Grade 3 or higher adverse events were observed. In addition, the treatment induced de-novo, neoantigen-specific T cell response in half (8/16) of these patients from undetectable levels to large fractions of all blood T cells (median 2.9%). At an early median follow-up of 18 months, patients with de-novo immune response (n=8) had a significantly longer recurrence-free survival (RFS) as compared to those without vaccine-induced immune responses (n=8) (median not reached vs. 13.4 months, HR 0.08, 95% CI 0.01-0.4, P = 0.003). Based on these data, BioNTech and Genentech are planning a randomized study to further evaluate the efficacy and safety of autogene cevumeran in combination with atezolizumab and chemotherapy in patients with resected PDAC. The investigator-initiated, single-center, Phase 1 trial (NCT04161755) was designed to evaluate the treatment of the companies’ individualized immunotherapy candidate autogene cevumeran in combination with the anti-PDL-1 immune checkpoint inhibitor atezolizumab as an add-on to the standard-of-care regimen with adjuvant chemotherapy mFOLFIRINOX in patients with resected PDACs. The primary objective of the study is to assess the safety. Secondary objectives include the efficacy of the treatment measured as the 18-month RFS, the immunogenicity as well as the feasibility of the treatment regimen. BioNTech’s iNeST platform previously demonstrated encouraging results with a tolerable safety profile of autogene cevumeran as single agent and in combination with atezolizumab in a heterogenous patient population with advanced and heavily pretreated solid tumors. In a Phase1a/b trial autogene cevumeran revealed robust CD8+ and CD4+ T cell responses and a manageable safety profile (NCT03289962). In October 2021, BioNTech announced that the first patient was dosed in a randomized Phase 2 trial (NCT04813627) of autogene cevumeran in the adjuvant treatment of post-operative circulating tumor DNA (ctDNA) positive, surgically resected colorectal cancer. BioNTech and Genentech are also conducting a Phase II proof-of-concept study, which is designed to evaluate autogene cevumeran plus pembrolizumab in the first-line treatment of advanced melanoma (NCT03815058).

Negative

BioNTech SE Approves Board Appointments

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl as supervisory board members. Prof. Dr. Anja Morawietz is Professor of External Accounting and General Business Administration at the Nuremberg University of Applied Sciences Georg Simon Ohm. She has in-depth expertise in accounting and auditing. In her research, she covers financial and sustainability reporting as well as developments in corporate governance. Prof. Dr. Rudolf Staudigl is an independent consultant and member of the Supervisory Board of TÜV Süd AG. He has extensive knowledge of production, science, and international markets, with a focus on China and India. He also has a deep understanding of biotechnology products having served for many years as Chairman of the Board of Directors of Wacker Chemie AG.

Positive

BioNTech SE Approves Special Cash Dividend

2022-06-01 17:15:00

BioNTech SE announced that at its AGM held on June 1, 2022, the shareholders approved special cash dividend of EUR 2.00 per ordinary share (including those held in the form of ADSs).

Neutral

BioNTech SE Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 02:00 PM

2022-05-31 14:08:00

BioNTech SE Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 02:00 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Positive

Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose

2022-05-23 10:45:00

Pfizer Inc. and BioNTech SE announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available. In the Phase 2/3 trial, 1,678 children received a third dose of the 3-µg formulation at least two months after the second dose at a time when Omicron was the predominant variant. The immunogenicity analysis of geometric mean titer (GMT) ratio and seroresponse rate was conducted on a subset of study participants one month following the third dose in children 6 months to under 5 years of age, compared to the second dose in the 16- to 25-year-old population. Non-inferiority was met for both the 6- to 24-month-old population and the 2- to under 5-year-old population for both co-primary endpoints. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was well-tolerated in this age group, and no new safety signals were identified. The majority of adverse events were mild or moderate. Studies in adults, adolescents, and children over 5 years of age continue to indicate that three doses of the Pfizer-BioNTech COVID-19 Vaccine enhances protection compared to two doses. The safety, immunogenicity and vaccine efficacy data for three doses of the vaccine in children under 5 years of age are consistent with the data seen in adults, suggesting that a third dose will provide similar benefit in children. In February 2022, the companies initiated a rolling submission for Emergency Use Authorization (EUA) of their COVID-19 vaccine in children 6 months to under 5 years of age, following a request by the U.S. Food and Drug Administration (FDA). At that time, a two-dose series was determined to be well-tolerated in this age group. Pfizer and BioNTech plan to submit these new safety, immunogenicity, and vaccine efficacy data on three doses to the rolling U.S. EUA application this week, with submissions to regulators worldwide to follow. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. The trial evaluated the safety, tolerability, and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

Negative

BioNTech SE and Pfizer Inc. Announces the U.S. Food and Drug Administration Expands Emergency Use Authorization

2022-05-17 21:14:00

On May 17, 2022, BioNTech SE and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.

Positive

Pfizer and BioNTech SE Granted U.S. Emergency Use Authorization for Booster Dose of Their Covid-19 Vaccine in Children 5 Through 11 Years of Age

2022-05-17 15:40:00

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. To date, more than 8 million5- to 11-year-olds in the U.S. have completed primary series. The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed. The third dose was well tolerated, with a safety profile similar to the two-dose primary series. This Phase 2/3 data builds on efficacy data for the primary two-dose series which showed 90.7% efficacy in children 5 through 11 without prior SARS-CoV-2 infection, measured from 7 days after the second dose, at a period when Delta was the prevalent strain. The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 Vaccine is the only COVID-19 vaccine authorized for use in the U.S. for children 5 through 11 years of age. The Phase 1/2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of a3-µg formulation of the Pfizer-BioNTech COVID-19 Vaccine on a three-dose schedule in children ages 6 months through 4 years (also known as under 5) is ongoing. Initial data is expected in the coming weeks.

Positive

Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement with European Commission

2022-05-16 11:49:00

Pfizer Inc. and BioNTech SE announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine. This amendment rephases planned deliveries to help support the European Commission and Member States' ongoing immunization programs, and is aligned to the companies' commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022. The companies' full-year 2022 revenue guidance and the full-year commitment of doses to be delivered to EC Member States in 2022 remain unchanged. Pfizer and BioNTech continue to evaluate potential adapted vaccines, including variant-based vaccines. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide. Primary Series a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise.

Neutral

BioNTech SE Presents at 8th Annual Immuno-Oncology Innovation Forum, May-25-2022 01:10 PM

2022-05-11 14:52:00

BioNTech SE Presents at 8th Annual Immuno-Oncology Innovation Forum, May-25-2022 01:10 PM.

Positive

BioNTech SE Proposes Special Cash Dividend

2022-05-09 10:01:00

The management board and supervisory board of BioNTech SE have proposed a special cash dividend of €2.00 per ordinary share (including those held in the form of ADSs), which corresponds to an aggregate of approximately €486.0 million, based on the number of ordinary shares and ADSs outstanding as of April 30, 2022, pending approval at the Annual General Meeting to be held in June 2022, which the company expects to serve as the record date for the dividend.

Neutral

BioNTech SE Reiterates Earnings Guidance for the Year 2022

2022-05-09 10:01:00

BioNTech SE reiterated earnings guidance for the year 2022. The company reiterates its prior 2022 financial year outlook.

Neutral

Tranche Update on BioNTech SE (NasdaqGS:BNTX)'s Equity Buyback Plan announced on March 31, 2022.

2022-05-09 07:06:00

From March 31, 2022 to March 31, 2022, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for $0 million under the buyback announced on March 31, 2022.

Positive

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

2022-04-27 00:00:00

BioNTech SE, $ 1.549832, Cash Dividend, Jun-02-2022

Positive

BioNTech SE and Pfizer Inc. Submits Application to U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of A 10- G Booster Dose

2022-04-26 21:11:00

On April 26, 2022, BioNTech SE and Pfizer Inc. submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10- g booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2 3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10- g two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals. The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

BioNTech SE Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022

2022-04-23 17:57:00

BioNTech SE Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022 . Venue: Boston, Massachusetts, United States. Speakers: Andreas Kuhn, Vice President RNA Biochemistry & Manufacturing, Jesse Dong, Vice President, Peptide Chemistry, Ugur Sahin, Co-Founder, CEO & Member of Management Board.

Neutral

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022

2022-04-23 07:45:00

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022. Venue: Boston, Massachusetts, United States.

Neutral

Biontech Se Proposes Amendment to Its Articles of Association

2022-04-21 10:07:00

Currently, the Supervisory Board consists of four members according to Sec. 9 para. 1 of the Articles of Association of the Biontech Se. The number of Supervisory Board members shall be increased to six in the future. This expansion takes into account the continuing growth of the Company and opens up the possibility of gaining additional expertise for the work of the Supervisory Board. The two additional seats on the Supervisory Board are to be filled by the election of two additional Supervisory Board members proposed under agenda item 8 of the Annual General Meeting.

Neutral

BioNTech SE - Shareholder/Analyst Call

2022-04-21 10:07:00

Annual General Meeting

Neutral

BioNTech SE Presents at 5th European Neoantigen Summit 2022, Apr-27-2022 05:00 PM

2022-04-15 10:08:00

BioNTech SE Presents at 5th European Neoantigen Summit 2022, Apr-27-2022 05:00 PM. Venue: Amsterdam, Netherlands. Speakers: Heinrich Haas, Vice President Formulation and Drug Development.

Positive

Pfizer Inc. and BioNTech SE Announce Data Demonstrating High Immune Response Following Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age

2022-04-14 10:46:00

Pfizer Inc. and BioNTech SE announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. These data demonstrate an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine compared to two doses. These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group. In the Phase 2/3 clinical trial, data were analyzed from 140 children 5 through 11 years of age received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 vaccine 10-µg primary series. Data from a sub analysis of 30 sera from this study indicate that serum antibodies induced by a third dose neutralize the SARS-CoV-2 Omicron variant in this age group, as demonstrated by a 36-fold increase in neutralizing antibody titers compared to levels seen after two doses of the Pfizer-BioNTech COVID-19 Vaccine. A robust response was observed regardless of prior SARS-CoV-2 infection. Further, immunogenicity data from 140 participants in the Phase 2/3 clinical trial with who had no evidence of prior SARS-CoV-2 infection showed a 6-fold increase (95% CI: 5.0, 7.6) in SARS-CoV-2 wild-type strain–neutralizing geometric mean titers (GMTs) one month after the booster compared to the SARS-CoV-2–neutralizing GMTs one month after the second dose of the Pfizer-BioNTech COVID-19 vaccine, demonstrating a strong immune response in this age group. To date, more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech COVID-19 vaccine, and in this most recent booster data readout (n=401), the vaccine was well tolerated with no new safety signals observed. Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose for children ages 5 through 11 in the U.S. in the coming days. The companies also plan to share these data with the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible. A primary series of two 10-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA for this age group in October 2021. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. About the Phase 1/2/3 Trial in Children - The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age. To evaluate the effectiveness of a third 10-µg dose in children 5 through 11 years of age, Pfizer and BioNTech tested a panel of 30 human immune sera obtained from the blood of individuals that received two or three 10-µg doses of the current Pfizer-BioNTech COVID-19 Vaccine, using a live SARS-CoV-2 recombinant virus fluorescent foci reduction neutralization test (FFRNT). Each serum was tested simultaneously for its neutralizing titer against recombinant SARS-CoV-2 (with USA-WA-1/2020 genetic backbone) bearing the wild-type SARS-CoV-2 spike protein and theOmicron spike. The 50% neutralizing geometric mean titer (GMT) against Omicron was 993 (after three doses), compared to 27 after two doses. The neutralizing GMT against the wild-type virus was 2153 (after three doses), compared to 335 after two doses. Further analysis will assess the persistence of neutralizing titers over time after a booster dose of the Pfizer-BioNTech COVID-19 Vaccine against the Omicron and wild-type strains. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series - a 2-dose primary series to individuals 5 years of age and older; and a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise. Booster Series - a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA); a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series; a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Positive

BioNTech SE announced that it has received $149.999985 million in funding from Pfizer Inc.

2022-04-14 00:00:00

On April 14, 2022, BioNTech SE closed the transaction. The company received $149,999,985 in the transaction. The transaction included participation from 1 investor.

Positive

BioNTech and Matinas BioPharma Announce Exclusive Research Collaboration to Evaluate Novel Delivery Technology for mRNA-based Vaccines

2022-04-11 11:00:00

BioNTech SE and Matinas BioPharma announced that they have entered into an exclusive research collaboration to evaluate the combination of mRNA formats and Matinas’ proprietary LNC platform technology. The parties will closely collaborate on formulation, optimization, and in vitro testing. Under the terms of the agreement, Matinas will receive an upfront access fee to work exclusively with BioNTech, as well as additional research funding from BioNTech. The parties have also commenced discussions on a license agreement for Matinas’ LNC platform technology.

Positive

BioNTech Presents Positive Preliminary Phase 1/2 Data for First-In-Class CAR-T Program BNT211 at AACR

2022-04-11 07:55:00

BioNTech SE presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. The preliminary results demonstrated an encouraging safety profile and anti-tumor activity in testicular cancer patients at the first evaluated dose levels of BNT211. The presentation included data from 16 patients who received CLDN6 CAR-T cells at dose levels 1 (1x107 CAR-T cells) and 2 (1x108 CAR-T cells) alone or combined with CARVac. Tumor indications included testicular cancer (n=8) ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. All 16 patients showed robust CAR-T cell expansion 10-17 days after infusion with cell frequencies close to 109 total counts in dose level 2. Adverse events and dose limiting toxicities were manageable; cytokine release syndromes of grade 1 and 2 and one transient occurrence of neurotoxicity grade 1 were observed. At the first efficacy assessment 6 weeks post infusion, 6 of 14 evaluable patients showed a partial response, and 5 patients had stable disease with shrinkage of target lesions. One patient showed no change from baseline and two patients were progressing. Responses were seen in testicular (n=4) and ovarian cancer (n=2) patients. At 12 weeks, 4 of the 6 patients with a partial response showed deepening and durability of responses with one patient reaching a complete response 18 weeks after infusion. All 4 testicular cancer patients in the higher dose level had disease control and 3 of these patients showed objective responses. In addition, 1 testicular cancer patient showed partial response after infusion of the lowest CAR-T dose level in combination with CARVac. Antitumor activity tended to be higher at the higher CAR-T dose and when combined with the vaccine, with 4 of 5 patients in the CARVac combination group showing a partial response. The ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) aims to evaluate the safety and preliminary efficacy of the CLDN6 CAR-T therapy alone and in combination with CARVac in heavily pretreated patients with CLDN6-positive relapsed or refractory advanced solid tumors and is conducted at multiple sites across Germany and the Netherlands. The next data update is expected later this year.

Neutral

BioNTech SE Receives Pandemic Preparedness Contract by German Federal Ministry of Health

2022-04-08 13:24:00

BioNTech SE announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Germany. The framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany. Under the preparedness agreement, BioNTech will reserve and maintain manufacturing capabilities to produce at least 80 million mRNA-based vaccine doses per year. The contract has an initial term of five years.

Neutral

Terrapinn Limited, World Vaccine Congress Europe 2022, Oct 11, 2022 through Oct 14, 2022

2022-04-03 10:12:00

Terrapinn Limited, World Vaccine Congress Europe 2022, Oct 11, 2022 through Oct 14, 2022. Venue: Palau de Congressos de Barcelona, FIRA Montjuic, Barcelona, Spain.

Neutral

Sachs Associates Ltd., 8th Annual Immuno-Oncology Innovation Forum, May 24, 2022 through May 25, 2022

2022-04-01 11:05:00

Sachs Associates Ltd., 8th Annual Immuno-Oncology Innovation Forum, May 24, 2022 through May 25, 2022.

Neutral

Sachs Associates Ltd., 22nd Annual Biotech in Europe Forum, Sep 21, 2022 through Sep 22, 2022

2022-04-01 11:05:00

Sachs Associates Ltd., 22nd Annual Biotech in Europe Forum, Sep 21, 2022 through Sep 22, 2022.

Positive

BioNTech SE (NasdaqGS:BNTX) announces an Equity Buyback for $1,500 million worth of its shares.

2022-03-31 07:09:00

BioNTech SE (NasdaqGS:BNTX) announces a share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of its American depositary shares (ADSs). The company expects to use all or a portion of the ADSs to satisfy upcoming settlement obligations under the company’s share-based payment arrangements. The program is valid for 2 years.

Positive

BioNTech SE authorizes a Buyback Plan.

2022-03-31 00:00:00

The Board of Directors of BioNTech SE has authorized a buyback plan on March 31, 2022.

Positive

BioNTech Seeks Acquisitions

2022-03-30 12:00:00

BioNTech SE (NasdaqGS:BNTX) is looking for acquisitions. Jens Holstein, Chief Financial Officer said, "To supplement our technologies and digital capabilities, we strive to extend and augment our expertise with synergistic acquisitions and collaborations". Ryan Richardson, Chief Strategy Officer said, "we expect to remain active on the corporate development front. Already this year, we have announced a diverse set of new collaborations with Pfizer, Regeneron, Medigene and Crescendo. We will continue to expand our access to complementary technologies in the field of synthetic biology. And we will continue to invest in our manufacturing infrastructure and digital capabilities. This could include new partnerships, M&A and in-licensing deals in addition to organic investment".

Neutral

Biontech Se Provides Revenue Guidance for the Financial Year 2022

2022-03-30 11:25:00

BioNTech SE provided revenue guidance for the financial year 2022. For the year, the company expects revenue of €13 billion - €17 billion.

Positive

BioNTech SE Proposes Special Cash Dividend

2022-03-30 10:00:00

BioNTech SE will proposed a special cash dividend of €2.00 per share at forthcoming 2022 Annual General Meeting.

Neutral

BioNTech SE - Analyst/Investor Day

2022-03-30 10:00:00

Capital Markets Day for analysts and investors

Positive

BioNTech SE's Board intends to launch an Equity Buyback.

2022-03-30 00:00:00

On March 30, 2022, the company announced that its Board of Directors will consider a proposal for share repurchase program. Under the program, the company will repurchase up to $1,500 million worth of its American Depositary Shares. The repurchased shares will be held as treasury shares. The program will be valid for a period of 2 years.

Positive

Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older

2022-03-29 14:30:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses. The expanded EUA is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers 18 years of age and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose.1 No new safety concerns were noted among study participants.1 The companies also shared with the FDA data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster,2-6 and evidence from Israel that an additional booster dose can improve protection against severe disease and death. The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized now for those age 50 years and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned. U.S. Indication & Authorized Use: The vaccine will be given as an injection into the muscle. Primary Series: In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise. Booster Dose: A first booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older. A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose. A second booster dose may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any of authorized COVID-19 vaccine. A second booster dose of the vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized COVID-19 vaccine to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: a 2-dose primary series to individuals 5 years of age and older a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older It is also authorized under EUA to provide: a 2-dose primary series to individuals 12 through 15 years of age. a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series. a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

Neutral

BioNTech SE Presents at 14th Kempen Life Sciences Conference, Apr-20-2022

2022-03-29 06:52:00

BioNTech SE Presents at 14th Kempen Life Sciences Conference, Apr-20-2022 . Venue: Amsterdam, Netherlands.

Neutral

JPMorgan Chase & Co., JP Morgan 11th Annual Napa Valley Biotech Forum, Apr 05, 2022

2022-03-27 23:13:00

JPMorgan Chase & Co., JP Morgan 11th Annual Napa Valley Biotech Forum, Apr 05, 2022. Venue: San Francisco, United States.

Neutral

BioNTech SE Presents at JP Morgan 11th Annual Napa Valley Biotech Forum, Apr-06-2022 10:00 AM

2022-03-27 23:13:00

BioNTech SE Presents at JP Morgan 11th Annual Napa Valley Biotech Forum, Apr-06-2022 10:00 AM. Venue: San Francisco, United States.

Neutral

BioNTech SE Presents at Jefferies Biotech on the Bay Summit, Apr-26-2022

2022-03-27 23:13:00

BioNTech SE Presents at Jefferies Biotech on the Bay Summit, Apr-26-2022 . Venue: St. Regis, Bal Harbour, Florida, United States.

Neutral

Jefferies LLC, Jefferies Biotech on the Bay Summit, Apr 26, 2022 through Apr 27, 2022

2022-03-25 10:39:00

Jefferies LLC, Jefferies Biotech on the Bay Summit, Apr 26, 2022 through Apr 27, 2022. Venue: St. Regis, Bal Harbour, Florida, United States.

Neutral

BioNTech SE Presents at Bank of America 2022 Healthcare Conference, May-12-2022 08:00 AM

2022-03-22 05:03:00

BioNTech SE Presents at Bank of America 2022 Healthcare Conference, May-12-2022 08:00 AM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Neutral

BioNTech SE Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-03-2022 09:00 AM

2022-03-18 04:06:00

BioNTech SE Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-03-2022 09:00 AM. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States. Speakers: Ugur Sahin, Co-Founder, CEO & Member of Management Board.

Neutral

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022

2022-03-17 15:04:00

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States.

Neutral

BioNTech SE Presents at The 13th Global Drug Delivery & Formulation Summit, Jun-27-2022

2022-03-03 04:09:00

BioNTech SE Presents at The 13th Global Drug Delivery & Formulation Summit, Jun-27-2022 . Venue: Berlin, Germany. Speakers: Heinrich Haas, Vice President Formulation & Drug Delivery.

Neutral

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States.

Neutral

Mark Allen Holdings Limited, the 13th Global Drug Delivery & Formulation Summit, Jun 27, 2022 through Jun 29, 2022

2022-02-16 09:24:00

Mark Allen Holdings Limited, The 13th Global Drug Delivery & Formulation Summit, Jun 27, 2022 through Jun 29, 2022. Venue: Berlin, Germany. Formulation design for poorly soluble compoundsThe potential of nanotechnology for better deliverabilityThe latest controlled released technologiesImproving patient compliance by harnessing data and thelatest smart device technologyOptimising formulations for continuous manufacturingOvercoming the blood brain barrier and challenges in oraldelivery of biologicsReformulation and biosimilarsDay 1 7:40 AM - 8:40 AMRegistration & Refreshments8:40 AM - 8:50 AMChair's Opening Remarks8:50 AM - 9:35 AM - Panel Discussion9:40 AM - 10:10 AM - Case Studies10:15 AM - 10:45 AM - Solution Spotlights10:45 AM - 11:35 AM1-2-1 Pre-Scheduled Meetings & Networking Break12:10 PM - 12:55 PM - Solution Spotlights12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:25 PM - Panel Discussion2:30 PM - 3:00 PM - Solution Spotlights3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - Case Studies5:15 PM - 6:00 PM - Panel DiscussionDevice DevelopmentImproving Patient Experience Through Digital and Combination Products6:00 PM - 6:05 PMChair’s Closing Remarks6:05 PM - 7:05 PMEvening Networking ReceptionDay 28:00 AM - 8:30 AMRegistration & Refreshments8:30 AM - 8:45 AMChair's Opening Remarks8:45 AM - 9:15 AM - Keynote9:20 AM - 9:50 AM - Case Studies9:55 AM - 10:25 AM - Solution Spotlights10:25 AM - 11:15 AM1-2-1 Pre-Scheduled Meetings & Networking Break11:15 AM - 11:45 AM - Case Studies11:50 AM - 12:20 PM - Solution SpotlightsTechnology & Innovation12:25 PM - 12:55 PM - Case Studies12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:25 PM - Case Studies2:30 PM - 3:00 PM - Solution Spotlights3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - KeynoteTechnology & Innovation5:10 PM - 5:15 PMChair’s Closing Remarks5:15 PM - 6:15 PMEvening Networking ReceptionDay 38:30 AM - 9:00 AMRegistration & Refreshments9:00 AM - 9:05 AMChair’s Opening Remarks9:20 AM - 9:50 AM - KeynoteTechnology & InnovationReducing the Cost of Developing Medical Devices9:55 AM - 10:25 AM - Case Studies10:30 AM - 11:00 AM - Solution Spotlights11:00 AM - 11:50 AM1-2-1 Pre-Scheduled Meetings & Networking Break11:50 AM - 12:20 PM - Case Studies12:25 PM - 12:55 PM - Solution Spotlights12:55 PM - 1:55 PMNetworking Lunch1:55 PM - 2:40 PM - Case Studies2:45 PM - 3:15 PM - Case Studies3:15 PM - 4:05 PM1-2-1 Pre-Scheduled Meetings & Networking Break4:05 PM - 4:35 PM - Case Studies4:40 PM - 5:10 PM - KeynoteTechnology & Innovation5:10 PM - 5:25 PMPoster Presentation Award5:25 PM - 5:30 PMChair’s Closing Remarks.

Neutral

Hanson Wade Limited, 5th European Neoantigen Summit 2022, Apr 26, 2022 through Apr 28, 2022

2022-02-16 04:05:00

Hanson Wade Limited, 5th European Neoantigen Summit 2022, Apr 26, 2022 through Apr 28, 2022. Venue: Amsterdam, Netherlands.

Neutral

BioNTech SE Presents at Eighth Annual Berenberg Conference USA 2022, May-23-2022 10:15 AM

2022-02-15 17:59:00

BioNTech SE Presents at Eighth Annual Berenberg Conference USA 2022, May-23-2022 10:15 AM. Venue: Tarrytown House Estate, 49 East Sunnyside Lane, Tarrytown, New York, New York, United States. Speakers: Ryan Richardson, Chief Strategy Officer, MD & Member of Management Board.

Neutral

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Positive

Pfizer and BioNTech Provides Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age

2022-02-11 18:30:00

Pfizer Inc. and BioNTech SE announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA. The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge. In December 2021, Pfizer and BioNTechannounced that the ongoing clinical study would evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April. The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen. The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.

Neutral

BioNTech SE to Report Q4, 2021 Results on Mar 30, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q4, 2021 results at 8:00 AM, US Eastern Standard Time on Mar 30, 2022

Neutral

BioNTech SE to Report Q1, 2022 Results on May 09, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q1, 2022 results at 8:00 AM, US Eastern Standard Time on May 09, 2022

Neutral

BioNTech SE to Report Q2, 2022 Results on Aug 08, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q2, 2022 results at 8:00 AM, US Eastern Standard Time on Aug 08, 2022

Neutral

BioNTech SE to Report Q3, 2022 Results on Nov 07, 2022

2022-02-11 14:53:00

BioNTech SE announced that they will report Q3, 2022 results at 8:00 AM, US Eastern Standard Time on Nov 07, 2022

Neutral

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022

2022-02-08 07:31:00

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Positive

Pfizer Inc. and BioNTech SE Initiate Rolling Submission for Emergency Use Authorization of Their Covid-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

2022-02-01 21:27:00

Pfizer Inc. and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA. Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S.,i with children under 4 accounting for more than 1.6 million of those cases.ii Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.2 If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern. The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity and available efficacy of two doses of the Pfizer-BioNTech COVID-19 Vaccine. The companies also plan to share these data with the European Medicines Agency and other regulatory agencies around the world. The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application. The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 2022.

Neutral

SwedenBIO Service AB, 2022 Nordic Life Science days, Sep 28, 2022 through Sep 29, 2022

2022-01-24 16:37:00

SwedenBIO Service AB, 2022 Nordic Life Science days, Sep 28, 2022 through Sep 29, 2022. Venue: Malmo, Sweden.

Neutral

BioNTech SE, Annual General Meeting, Jun 01, 2022

2022-01-24 00:05:00

BioNTech SE, Annual General Meeting, Jun 01, 2022, at 14:00 Central European Standard Time. Agenda: To consider the presentation of the adopted annual financial statements, the approved consolidated financial statements, and the combined management report for the company and the group as well as the report of the supervisory board for the company, each for the 2021 financial year or as of 31 December 2021, respectively; to consider and pass the resolution on the appropriation of the balance sheet profit; and to discuss other matters.

Neutral

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

2022-01-07 14:32:00

BioNTech SE, Q4 2021 Earnings Call, Mar 30, 2022

Neutral

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

2022-01-07 14:32:00

BioNTech SE, Q1 2022 Earnings Call, May 09, 2022

Neutral

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

2022-01-07 14:32:00

BioNTech SE, Q2 2022 Earnings Call, Aug 08, 2022

Neutral

BioNTech SE, Q3 2022 Earnings Call, Nov 07, 2022

2022-01-07 14:32:00

BioNTech SE, Q3 2022 Earnings Call, Nov 07, 2022

Negative

U.S. Food and Drug Administration Expands the Emergency Use Authorization of Booster Dose of the Pfizer and Biontech

2022-01-03 21:39:00

On January 3, 2022, BioNTech SE and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age and older.

Positive

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

2022-01-03 14:45:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series. A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.

Neutral

Joh. Berenberg, Gossler & Co. KG, The Goldman Sachs Group, Inc., Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep 19, 2022 through Sep 21, 2022

2021-12-28 03:56:00

Joh. Berenberg, Gossler & Co. KG, The Goldman Sachs Group, Inc., Berenberg & Goldman Sachs 11th German Corporate Conference 2022, Sep 19, 2022 through Sep 21, 2022. Venue: Infinity Munich Hotel, Andreas-Danzer-Weg 1, 85716 Unterschleißheim, Munningen, Germany.

Neutral

Joh. Berenberg, Gossler & Co. KG, Eighth Annual Berenberg Conference USA 2022, May 23, 2022 through May 25, 2022

2021-12-21 05:07:00

Joh. Berenberg, Gossler & Co. KG, Eighth Annual Berenberg Conference USA 2022, May 23, 2022 through May 25, 2022. Venue: Tarrytown House Estate, 49 East Sunnyside Lane, Tarrytown, New York, New York, United States. The conference will bring together companies to present their corporate strategy, current trends and challenges. Running in parallel with the main presentations, companies will be hosting small group and one-on-one meetings.

Neutral

Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply

2021-12-20 15:05:00

Pfizer Inc. and BioNTech SE announced an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY®, the companies’ COVID-19 vaccine. Contractual details are currently being finalized. These 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to the EC member states by the companies in 2022 will now total more than 650 million doses. This order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved. Pfizer and BioNTechagreed in May to supply 900 million doses to the European Commission (EC) in 2022 and 2023, with option to request up to an additional 900 million doses. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Positive

Pfizer Inc. and BioNTech SE Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

2021-12-09 17:15:00

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 16 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series. A booster dose of the Pfizer-BioNTech COVID-19 vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 18 years of age and older, as well as for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Pfizer and BioNTech plan to submit a supplemental Biologics License Application (sBLA) for approval of a booster dose of their COVID-19 vaccine in individuals 16 years of age and older. The sBLA will include efficacy and safety data from a Phase 3 trial showing that a 30-µg booster dose administered to individuals 16 years and older who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. These are the first efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile. Pfizer and BioNTech continue to supply the vaccine, including booster doses, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world. The Phase 3 trial evaluated the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine in more than 10,000 individuals 16 years of age and older in the United States, Brazil, and South Africa. All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech COVID-19 Vaccine, and then were randomized 1:1 to receive either a 30-µg booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years of age, and 23.3% of participants 65 years of age and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Neutral

BioNTech SE - Special Call

2021-12-08 12:15:00

To Provide an Update on Omicron Variant

Positive

Pfizer and BioNTech Provide Update on Omicron Variant

2021-12-08 11:54:00

Pfizer Inc. and BioNTech SE announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccines one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses. Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant. However, as the vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron, the companies believe that vaccinated individuals may still be protected against severe forms of the disease and are closely monitoring real world effectiveness against Omicron, globally. A more robust protection may be achieved by a third dose as data from additional studies of the companies indicate that a booster with the current COVID-19 vaccine from Pfizer and BioNTech increases the antibody titers by 25-fold. According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants. A third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes which are considered to correlate with the protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant. While these results are preliminary, the companies will continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron and inform the most effective path forward. On November 25, the companies started to develop an Omicron-specific COVID-19 vaccine. The development will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. First batches of the Omicron-based vaccine can be produced and are planned to be ready for deliveries within 100 days, pending regulatory approval. Pfizer and BioNTech have tested other variant-specific vaccines as well, which have produced very strong neutralization titers and a tolerable safety profile. Based on this experience the companies have high confidence that if needed they can deliver an Omicron-based vaccine in March 2022. The companies have also previously initiated clinical trials with variant-specific vaccines (Alpha, Beta, Delta & Alpha/Delta Mix) and data from these studies will be submitted to regulatory agencies around the world to help accelerate the process of adapting the vaccine and gaining regulatory authorization or approval of an Omicron-specific vaccine, if needed. The companies have previously announced that they expect to produce four billion doses of BNT162b2 in 2022, and this capacity is not expected to change if an adapted vaccine is required.

Fundamental Summary

BioNTech SE published its Q2 report on 2022-08-08 with positive results, but no significant factors particularly remarkable relative to its peers. We do believe, though, that macro-related market conditions will influence its performance more significantly than its individual results. Bottom line, BioNTech SE's financials indicate solid performance in terms of growth, value, and income, which leads us to believe that they may become interesting again in the next few months. But for right now, we gave the company an overall grade of 78 and a BUY recommendation.

BioNTech SE reported earnings results for the third quarter and nine months ended September 30, 2022. For the third quarter, the company reported sales was EUR 3,394.8 million compared to EUR 6,040.1 million a year ago. Revenue was EUR 3,461.2 million compared to EUR 6,087.3 million a year ago. Net income was EUR 1,784.9 million compared to EUR 3,211 million a year ago. Basic earnings per share from continuing operations was EUR 7.43 compared to EUR 13.14 a year ago. Diluted earnings per share from continuing operations was EUR 6.98 compared to EUR 12.35 a year ago.For the nine months, sales was EUR 12,923.3 million compared to EUR 13,348.1 million a year ago. Revenue was EUR 13,032.3 million compared to EUR 13,444.2 million a year ago. Net income was EUR 7,155.7 million compared to EUR 7,126.3 million a year ago. Basic earnings per share from continuing operations was EUR 29.47 compared to EUR 29.22 a year ago. Diluted earnings per share from continuing operations was EUR 27.7 compared to EUR 27.46 a year ago.

Business Description

BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. The company is developing FixVac product candidates, including BNT111, which is in Phase II clinical trial for advance melanoma; BNT112 that is in Phase I/IIa clinical trial for prostate cancer; BNT113, which is in Phase II clinical trial to treat HPV+ head and neck cancers; BNT114 that is in Phase I clinical trial for triple negative breast cancer; BNT115, which is in Phase I clinical trial in ovarian cancer; and BNT116, a preclinical stage product for non-small cell lung cancer. It also develops neoantigen specific immunotherapies, such as Autogene cevumeran (BNT122), which is in Phase II clinical trial for first-line melanoma, as well as in Phase 1a/1b clinical trial to treat multiple solid tumors; mRNA intratumoral immunotherapy comprising SAR441000 that is in Phase I clinical trial for solid tumors; and BNT141 and BNT142 that are in Phase I clinical trial to treat multiple solid tumors. In addition, the company develops RiboCytokines, which include BNT151, BNT152, and BNT153 to treat solid tumors; chimeric antigen receptor T cell immunotherapies, such as BNT211 to treat multiple solid tumors, and BNT221 for other cancers; and checkpoint immunomodulators consisting of GEN1046 and GEN1042, which are in Phase I/II clinical trial to treat solid tumors. Further, it develops BNT321, an IgG1 monoclonal antibody in Phase II clinical trial for pancreatic cancer; BNT411, a small molecule immunomodulator product candidate for solid tumors; prophylactic vaccine for COVID-19 and Influenza; and infectious disease immunotherapies and rare disease protein replacement therapies. The company has collaborations with Genentech, Inc.; Sanofi S.A.; Genmab A/S; Pfizer Inc.; Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; and Regeneron Pharmaceuticals, Inc. BioNTech SE was incorporated in 2008 and is headquartered in Mainz, Germany.

Sector Overview

BioNTech SE is included in the Biotechnology according to GICS (global industry classification standard). The Biotechnology industry, which is part of the Health Care sector, includes companies primarily engaged in R&D, manufacturing, and/or marketing of products based on genetic analysis and genetic engineering. BioNTech SE's industry and sector affiliation are expected to positively boost their relative likelihood to overperform the market looking forward, as they should benefit significantly from the macroeconomic environment we see now.

Fundamental Highlights


Parameter Value Change Score
Assets 21.2B 4.2% 74
Liabilities 4.3B -1.5% 71
Price to Book 2.1 -11.9% 82
Cash & Equivalents 9.3B 51.4% 94
Equity 16.8B 5.8% 51
EBITDA 15.4B -13.4% 53
Total Revenues 21.2B -9.1% 95
Parameter Value Change Score
Return on Equity 105.3 -24.6% 85
Net Cashflow 8.4B 59.7% 86
Capital Expenditure -192.4M -30.5% 44
Asset Turnover 1.4 -26.5% 44
Free Cashflow Per Share 37.0 78.5% 94
* All values are TTM

The below chart reflects BioNTech SE's birds-eye view on its performance with respect to its peers, the company's fillings as reported or to a similar industry, market cap, and country of origin. While BioNTech SE's peer average final assessment score stands on 58, BioNTech SE's score is 78.

  •  BNTX
  •  Peers average
Name Market Cap Balance Sheet Income Statement Cash Flow Rating Final Assessment mc_sort Hidden
Amgen Inc. 152.8B 83 81 79
Buy
84
84 0 1
Gilead Sciences, Inc. 110.2B 77 71 57
Hold
69
69 1 1
Vertex Pharmaceuticals Incorporated 81.2B 70 72 66
Hold
68
68 2 1
Regeneron Pharmaceuticals, Inc. 80.3B 73 69 61
Hold
66
66 3 1
Biogen Inc. 43.9B 82 76 68
Hold
77
77 4 1
Alnylam Pharmaceuticals, Inc. 27.1B 66 44 76
Underperform
56
56 5 1
Horizon Therapeutics Public Limited Company 22.7B 79 62 72
Hold
71
71 6 1
Seagen Inc. 22.5B 51 81 72
Hold
62
62 7 1
BeiGene, Ltd. 19.9B 57 65 66
Underperform
56
56 8 1
BioMarin Pharmaceutical Inc. 18.8B 72 83 72
Hold
76
76 9 1
Incyte Corporation 17.7B 70 59 69
Hold
63
63 10 1
United Therapeutics Corporation 12.8B 74 80 68
Hold
74
74 11 1
Neurocrine Biosciences, Inc. 12.2B 77 81 80
Buy
81
81 12 1
Sarepta Therapeutics, Inc. 10.8B 62 47 77
Underperform
56
56 13 1
Halozyme Therapeutics, Inc. 7.7B 72 79 59
Hold
69
69 14 1
Ascendis Pharma A/S 6.9B 59 44 85
Underperform
55
55 15 1
Ionis Pharmaceuticals, Inc. 5.8B 59 87 85
Hold
74
74 16 1
Apellis Pharmaceuticals, Inc. 5.5B 49 56 80
Underperform
53
53 17 1
Exelixis, Inc. 5.5B 58 77 80
Hold
67
67 18 1
Mirati Therapeutics, Inc. 5.3B 60 66 49
Underperform
52
52 19 1
Natera, Inc. 4.5B 49 72 76
Underperform
58
58 20 1
Alkermes plc 4.1B 59 57 57
Underperform
51
51 21 1
Cytokinetics, Incorporated 4.0B 53 53 61
Underperform
47
47 22 1
Arrowhead Pharmaceuticals, Inc. 3.4B 53 66 47
Underperform
47
47 23 1
PTC Therapeutics, Inc. 3.0B 45 77 89
Hold
62
62 24 1
IVERIC bio, Inc. 2.9B 54 57 64
Underperform
50
50 25 1
ACADIA Pharmaceuticals Inc. 2.5B 62 66 73
Hold
62
62 26 1
Insmed Incorporated 2.5B 44 53 68
Underperform
43
43 27 1
BioCryst Pharmaceuticals, Inc. 2.5B 44 73 72
Underperform
54
54 28 1
Ironwood Pharmaceuticals, Inc. 1.9B 75 75 74
Hold
75
75 29 1
Agios Pharmaceuticals, Inc. 1.7B 59 61 69
Underperform
57
57 30 1
Myriad Genetics, Inc. 1.6B 54 96 76
Hold
72
72 31 1
Syndax Pharmaceuticals, Inc. 1.4B 48 58 67
Underperform
48
48 32 1
FibroGen, Inc. 1.4B 55 60 50
Underperform
47
47 33 1
Novavax, Inc. 1.3B 49 66 78
Underperform
56
56 34 1
ImmunoGen, Inc. 1.1B 56 45 63
Underperform
46
46 35 1
Deciphera Pharmaceuticals, Inc. 1.1B 52 78 83
Hold
65
65 36 1
Enanta Pharmaceuticals, Inc. 910.7M 59 82 70
Hold
66
66 37 1
Geron Corporation 884.5M 55 53 60
Underperform
48
48 38 1
Bicycle Therapeutics plc 859.8M 60 63 51
Underperform
52
52 39 1
AnaptysBio, Inc. 785.6M 51 63 60
Underperform
50
50 40 1
Anavex Life Sciences Corp. 687.6M 55 78 76
Hold
64
64 41 1
Mersana Therapeutics, Inc. 664.5M 63 48 76
Underperform
57
57 42 1
bluebird bio, Inc. 645.9M 53 93 82
Hold
72
72 43 1
Intercept Pharmaceuticals, Inc. 617.5M 82 86 43
Hold
73
73 44 1
Sangamo Therapeutics, Inc. 599.8M 51 73 76
Underperform
60
60 45 1
Inovio Pharmaceuticals, Inc. 509.0M 51 73 73
Underperform
59
59 46 1
Anika Therapeutics, Inc. 460.8M 65 52 71
Underperform
57
57 47 1
Lexicon Pharmaceuticals, Inc. 403.9M 64 58 68
Underperform
58
58 48 1
MacroGenics, Inc. 395.3M 60 76 81
Hold
68
68 49 1
Precigen, Inc. 378.8M 76 80 65
Hold
74
74 50 1
Arbutus Biopharma Corporation 367.7M 45 61 72
Underperform
49
49 51 1
Adaptimmune Therapeutics plc 355.5M 50 61 54
Underperform
46
46 52 1
Humacyte, Inc. 321.7M 56 70 76
Hold
61
61 53 1
Acumen Pharmaceuticals, Inc. 232.5M 57 74 61
Underperform
58
58 54 1
Exact Sciences Corporation 8.0B 55 85 71
Hold
66
66 55 1
Amicus Therapeutics, Inc. 3.4B 55 61 85
Underperform
60
60 56 1
Xenon Pharmaceuticals Inc. 2.3B 49 63 55
Underperform
46
46 57 1
Abgenix Inc. 2.1B 57 48 59
Underperform
44
44 58 1
Fate Therapeutics, Inc. 2.0B 52 59 75
Underperform
54
54 59 1
Veracyte, Inc. 2.0B 67 52 82
Hold
62
62 60 1
Xencor, Inc. 1.8B 73 77 74
Hold
75
75 61 1
Celldex Therapeutics, Inc. 1.7B 51 43 63
Underperform
42
42 62 1
Catalyst Pharmaceuticals, Inc. 1.7B 76 80 76
Buy
78
78 63 1
Dynavax Technologies Corporation 1.6B 58 80 73
Hold
66
66 64 1
CureVac N.V. 1.4B 52 90 76
Hold
73
73 65 1
MannKind Corporation 1.2B 68 57 62
Underperform
58
58 66 1
Viridian Therapeutics, Inc. 1.0B 68 38 52
Underperform
46
46 67 1
Iovance Biotherapeutics, Inc. 1.0B 49 70 70
Underperform
55
55 68 1
Avid Bioservices, Inc. 973.5M 72 59 79
Hold
69
69 69 1
Northwest Biotherapeutics, Inc. 864.4M 62 67 53
Underperform
55
55 70 1
Agenus Inc. 823.0M 40 59 57
Underperform
40
40 71 1
Immatics N.V. 803.4M 81 82 78
Strong Buy
88
88 72 1
CTI BioPharma Corp. 763.9M 46 72 87
Underperform
60
60 73 1
Aurinia Pharmaceuticals Inc. 729.0M 53 77 77
Hold
64
64 74 1
Merus N.V. 710.7M 48 63 66
Underperform
50
50 75 1
CareDx, Inc 693.3M 41 57 56
Underperform
40
40 76 1
ADMA Biologics, Inc. 657.2M 58 75 77
Hold
65
65 77 1
Vanda Pharmaceuticals Inc. 617.4M 60 58 75
Underperform
59
59 78 1
Emergent BioSolutions Inc. 613.6M 46 83 58
Underperform
55
55 79 1
Sorrento Therapeutics, Inc. 603.6M 47 54 65
Underperform
45
45 80 1
Zymeworks Inc. 497.2M 45 90 77
Hold
64
64 81 1
Altimmune, Inc. 489.0M 55 89 71
Hold
67
67 82 1
Eagle Pharmaceuticals, Inc. 472.7M 56 81 58
Underperform
60
60 83 1
Amarin Corporation plc 464.4M 54 85 59
Hold
61
61 84 1
Albireo Pharma, Inc. 457.1M 55 64 59
Underperform
53
53 85 1
Sutro Biopharma, Inc. 420.1M 67 73 82
Hold
72
72 86 1
Aura Biosciences, Inc. 418.9M 45 61 68
Underperform
48
48 87 1
MiMedx Group, Inc. 368.9M 62 50 59
Underperform
51
51 88 1
Organogenesis Holdings Inc. 358.7M 57 58 66
Underperform
53
53 89 1
Silence Therapeutics plc 350.0M 67 73 69
Hold
69
69 90 1
AVEO Pharmaceuticals, Inc. 337.5M 64 77 75
Hold
69
69 91 1
Aldeyra Therapeutics, Inc. 327.9M 63 78 59
Hold
63
63 92 1
Heron Therapeutics, Inc. 322.2M 73 76 78
Hold
76
76 93 1
Affimed N.V. 319.6M 60 64 75
Underperform
60
60 94 1
CytoDyn Inc. 293.1M 58 96 81
Hold
76
76 95 1
Actinium Pharmaceuticals, Inc. 282.1M 62 74 72
Hold
65
65 96 1
Concert Pharmaceuticals, Inc. 231.1M 69 73 72
Hold
70
70 97 1

Macro Environment

Neutral
70

Typically, the stock market in Germany will react to recent economic events, as well as be influenced by the sentiment in other major economies around the world, such as the United States, European Union, and China. Our assessment is that these two events may influence global market sentiment. On the negative side we have the Europe's energy crisis, and on the positive side we have the Euro's weakness.

Positive Euro's weakness

With the US-EU interest rate gap widening, the dollar has strengthened against all major European currencies, including the Euro, British pound, and Norwegian krone. As a result, several European corporations saw increased earnings translated from foreign currencies. Firms in the Stoxx 600 Index derive more than half of their revenue from outside the region, and the U.S. is one of their biggest markets.

Negative Europe's energy crisis

The European Central Bank (ECB) has decided to raise the interest rate in the Eurozone by 0.75%, to 2%. This action was predicted as a result of strong European inflation, which hit 10% in September. Also, the European energy crisis continues, but despite everyone talking about a shortage until a few days ago, it seems there's actually a surplus. Despite the improved gas market, prices remain higher than the five-year average for this time of year, threatening to deplete inventory quickly due to extremely cold weather. Due to its lag behind other central banks around the world, the European Central Bank is expected to continue increasing interest rates in order to combat the continent's runaway inflation.

Besides the events we mentioned, there are also specific events related to the Pharmaceuticals, Biotechnology & Life Sciences industry of which BioNTech SE is a part. As a result, we believe that the rising inflation may cloud the sector's shares in the near time future.

Negative rising inflation

The sudden increase in inflation is generally regarded as the most painful since it takes companies several quarters to pass on higher input costs to consumers. Historically, companies traded in the Pharmaceuticals, Biotechnology & Life Sciences industry have been hit by high inflation times due to increased operating expenses and decreased revenues.

In considering the current macro environment and the risks that might affect BioNTech SE stock, we came to the conclusion that recent events aren't likely to affect the company's performance in the short term, and thus rated BioNTech SE macro environment with the score of 70.

Technical Analysis

When trying to optimize the timing of an investment, it's critical to analyze whether the stock looks overbought or oversold, and in which direction the momentum is moving. BioNTech SE's stock is now priced above its 5-day, 50-day, and 200-day moving average, while its MACD (moving average convergence divergence) indicates that the stock's price movement momentum is strengthening. Historically, this is a positive setup in the near, medium, and long-term. In particular, many institutional investors keep close watch of the 200-day moving average. Meanwhile, looking at the Stochastic Oscillator and RSI (relative strength index), BioNTech SE's stock indicates that it's likely oversold. Overall, these technical indicators signal positive upward momentum. Therefore, this stock received a cumulative TA (technical analysis) score of 78.

Bullish 78
Close Price 167.02
52W Low 118.43
52W High 344.06
5D MA 160.64
50D MA 143.82
200D MA 151.79
MACD 5.32
RSI 18.51
STOCH 100.0

Balance Sheet Analysis

All in all, looking at the balance sheet, BioNTech SE's financial health appears good. BioNTech SE's balance sheet neither stood out as being particularly strong or weak relative to its peers. BioNTech SE reported a positive trendline in their cash and cash equivalents metrics. Specifically, they reported that cash and cash equivalents were 9.3B, representing 51.4% change from the last report. This impressive growth, specifically in contrast to their industry peers' performance, should support an upswing in the company's stock price. Therefore, its cash and cash equivalents movement earned a score of 94. Also, BioNTech SE publishes solid book value factor metrics in this report. Price to book ratio (P/B) now sits at 2.1 and represents a -11.9% change from the previous report. These book value factor numbers show that management has been prudent in focusing on efficient growth. We believe the stock price has room to grow to reflect its intrinsic value accurately. Consequently, their book value factors movement received a grade of 82. On the other hand, Equity, jumped out as looking rather underwhelming. BioNTech SE reported weak equity changes momentum this period. At filing, equity was reported as 16.8B, representing 5.8% change from the previous report. This parameter often affects companies in the same industry and market capitalization by up to 12.1%. These metrics are all the more disappointing relative to their peers and should blunt potential positive momentum in its's stock price. Therefore, their equity movement component earned a score of 51. Therefore, we scored the company's balance sheet a 79.

Parameter Value Change Score
Assets 21.2B 4.2% 74
Liabilities 4.3B -1.5% 71
Price to Book 2.1 -11.9% 82
Cash & Equivalents 9.3B 51.4% 94
Equity 16.8B 5.8% 51
* All values are TTM

The below chart describes BioNTech SE's performance as reflected on its balance sheet with respect to its peers. While BioNTech SE received a balance sheet score of 79, the average of its peers stands on 59.

  •  BNTX
  •  Peers average
Name Market Cap Liabilities Movement Asset Change Equity/Intangibles Adjustments Cash & Equivalents Book Value Momentum Balance Sheet mc_sort Hidden
Amgen Inc. 152.8B 72.0 82.0 89.0 95.0 77.0 83 0 1
Gilead Sciences, Inc. 110.2B 84.0 79.0 59.0 69.0 85.0 77 1 1
Vertex Pharmaceuticals Incorporated 81.2B 67.0 74.0 58.0 76.0 82.0 70 2 1
Regeneron Pharmaceuticals, Inc. 80.3B 66.0 63.0 88.0 73.0 84.0 73 3 1
Biogen Inc. 43.9B 61.0 73.0 92.0 92.0 90.0 82 4 1
Alnylam Pharmaceuticals, Inc. 27.1B 69.0 78.0 99.0 95.0 37.0 66 5 1
Horizon Therapeutics Public Limited Company 22.7B 72.0 80.0 94.0 83.0 68.0 79 6 1
Seagen Inc. 22.5B 70.0 68.0 48.0 69.0 49.0 51 7 1
BeiGene, Ltd. 19.9B 67.0 61.0 69.0 61.0 61.0 57 8 1
BioMarin Pharmaceutical Inc. 18.8B 73.0 80.0 54.0 88.0 75.0 72 9 1
Incyte Corporation 17.7B 70.0 75.0 63.0 81.0 74.0 70 10 1
United Therapeutics Corporation 12.8B 61.0 82.0 55.0 87.0 83.0 74 11 1
Neurocrine Biosciences, Inc. 12.2B 82.0 81.0 47.0 90.0 85.0 77 12 1
Sarepta Therapeutics, Inc. 10.8B 64.0 75.0 54.0 87.0 62.0 62 13 1
Halozyme Therapeutics, Inc. 7.7B 37.0 83.0 97.0 94.0 62.0 72 14 1
Ascendis Pharma A/S 6.9B 71.0 68.0 59.0 58.0 63.0 59 15 1
Ionis Pharmaceuticals, Inc. 5.8B 73.0 68.0 60.0 41.0 64.0 59 16 1
Apellis Pharmaceuticals, Inc. 5.5B 67.0 58.0 48.0 65.0 57.0 49 17 1
Exelixis, Inc. 5.5B 70.0 61.0 52.0 78.0 67.0 58 18 1
Mirati Therapeutics, Inc. 5.3B 68.0 70.0 42.0 83.0 68.0 60 19 1
Natera, Inc. 4.5B 67.0 60.0 48.0 41.0 60.0 49 20 1
Alkermes plc 4.1B 69.0 73.0 63.0 74.0 52.0 59 21 1
Cytokinetics, Incorporated 4.0B 65.0 81.0 50.0 84.0 37.0 53 22 1
Arrowhead Pharmaceuticals, Inc. 3.4B 78.0 65.0 57.0 48.0 51.0 53 23 1
PTC Therapeutics, Inc. 3.0B 61.0 56.0 50.0 43.0 58.0 45 24 1
IVERIC bio, Inc. 2.9B 42.0 72.0 45.0 79.0 64.0 54 25 1
ACADIA Pharmaceuticals Inc. 2.5B 65.0 67.0 61.0 82.0 67.0 62 26 1
Insmed Incorporated 2.5B 80.0 63.0 41.0 69.0 37.0 44 27 1
BioCryst Pharmaceuticals, Inc. 2.5B 43.0 65.0 54.0 58.0 49.0 44 28 1
Ironwood Pharmaceuticals, Inc. 1.9B 78.0 79.0 56.0 84.0 79.0 75 29 1
Agios Pharmaceuticals, Inc. 1.7B 75.0 59.0 54.0 91.0 66.0 59 30 1
Myriad Genetics, Inc. 1.6B 63.0 60.0 49.0 76.0 66.0 54 31 1
Syndax Pharmaceuticals, Inc. 1.4B 62.0 62.0 42.0 41.0 61.0 48 32 1
FibroGen, Inc. 1.4B 71.0 62.0 54.0 61.0 62.0 55 33 1
Novavax, Inc. 1.3B 60.0 57.0 51.0 61.0 62.0 49 34 1
ImmunoGen, Inc. 1.1B 75.0 58.0 66.0 51.0 61.0 56 35 1
Deciphera Pharmaceuticals, Inc. 1.1B 66.0 64.0 46.0 46.0 64.0 52 36 1
Enanta Pharmaceuticals, Inc. 910.7M 71.0 73.0 51.0 94.0 54.0 59 37 1
Geron Corporation 884.5M 72.0 68.0 47.0 50.0 63.0 55 38 1
Bicycle Therapeutics plc 859.8M 72.0 63.0 63.0 66.0 66.0 60 39 1
AnaptysBio, Inc. 785.6M 61.0 63.0 48.0 51.0 64.0 51 40 1
Anavex Life Sciences Corp. 687.6M 65.0 66.0 65.0 66.0 54.0 55 41 1
Mersana Therapeutics, Inc. 664.5M 68.0 80.0 44.0 91.0 63.0 63 42 1
bluebird bio, Inc. 645.9M 62.0 69.0 42.0 50.0 63.0 53 43 1
Intercept Pharmaceuticals, Inc. 617.5M 97.0 77.0 37.0 96.0 99.0 82 44 1
Sangamo Therapeutics, Inc. 599.8M 75.0 70.0 42.0 50.0 52.0 51 45 1
Inovio Pharmaceuticals, Inc. 509.0M 62.0 58.0 64.0 39.0 61.0 51 46 1
Anika Therapeutics, Inc. 460.8M 64.0 73.0 61.0 64.0 73.0 65 47 1
Lexicon Pharmaceuticals, Inc. 403.9M 64.0 81.0 41.0 56.0 75.0 64 48 1
MacroGenics, Inc. 395.3M 69.0 59.0 64.0 97.0 64.0 60 49 1
Precigen, Inc. 378.8M 99.0 77.0 75.0 37.0 74.0 76 50 1
Arbutus Biopharma Corporation 367.7M 65.0 58.0 43.0 39.0 59.0 45 51 1
Adaptimmune Therapeutics plc 355.5M 65.0 57.0 53.0 50.0 63.0 50 52 1
Humacyte, Inc. 321.7M 81.0 60.0 59.0 58.0 59.0 56 53 1
Acumen Pharmaceuticals, Inc. 232.5M 71.0 74.0 53.0 74.0 51.0 57 54 1
Exact Sciences Corporation 8.0B 62.0 62.0 50.0 81.0 64.0 55 55 1
Amicus Therapeutics, Inc. 3.4B 65.0 60.0 57.0 86.0 60.0 55 56 1
Xenon Pharmaceuticals Inc. 2.3B 72.0 53.0 50.0 37.0 65.0 49 57 1
Abgenix Inc. 2.1B 78.0 52.0 79.0 92.0 47.0 57 58 1
Fate Therapeutics, Inc. 2.0B 76.0 58.0 56.0 93.0 48.0 52 59 1
Veracyte, Inc. 2.0B 68.0 77.0 53.0 82.0 71.0 67 60 1
Xencor, Inc. 1.8B 77.0 94.0 50.0 77.0 65.0 73 61 1
Celldex Therapeutics, Inc. 1.7B 62.0 61.0 47.0 43.0 66.0 51 62 1
Catalyst Pharmaceuticals, Inc. 1.7B 71.0 77.0 43.0 87.0 95.0 76 63 1
Dynavax Technologies Corporation 1.6B 62.0 68.0 44.0 50.0 76.0 58 64 1
CureVac N.V. 1.4B 64.0 62.0 55.0 57.0 44.0 52 65 1
MannKind Corporation 1.2B 66.0 84.0 43.0 93.0 70.0 68 66 1
Viridian Therapeutics, Inc. 1.0B 69.0 81.0 37.0 98.0 73.0 68 67 1
Iovance Biotherapeutics, Inc. 1.0B 72.0 58.0 64.0 81.0 41.0 49 68 1
Avid Bioservices, Inc. 973.5M 75.0 66.0 46.0 61.0 86.0 72 69 1
Northwest Biotherapeutics, Inc. 864.4M 73.0 82.0 45.0 95.0 51.0 62 70 1
Agenus Inc. 823.0M 76.0 57.0 43.0 59.0 37.0 40 71 1
Immatics N.V. 803.4M 68.0 80.0 40.0 81.0 90.0 81 72 1
CTI BioPharma Corp. 763.9M 64.0 60.0 41.0 38.0 60.0 46 73 1
Aurinia Pharmaceuticals Inc. 729.0M 71.0 71.0 56.0 40.0 51.0 53 74 1
Merus N.V. 710.7M 76.0 62.0 46.0 57.0 49.0 48 75 1
CareDx, Inc 693.3M 44.0 59.0 56.0 38.0 50.0 41 76 1
ADMA Biologics, Inc. 657.2M 76.0 68.0 55.0 43.0 65.0 58 77 1
Vanda Pharmaceuticals Inc. 617.4M 63.0 70.0 61.0 53.0 67.0 60 78 1
Emergent BioSolutions Inc. 613.6M 49.0 68.0 62.0 43.0 46.0 46 79 1
Sorrento Therapeutics, Inc. 603.6M 89.0 56.0 42.0 71.0 46.0 47 80 1
Zymeworks Inc. 497.2M 62.0 56.0 42.0 38.0 63.0 45 81 1
Altimmune, Inc. 489.0M 65.0 76.0 44.0 62.0 55.0 55 82 1
Eagle Pharmaceuticals, Inc. 472.7M 69.0 56.0 96.0 38.0 54.0 56 83 1
Amarin Corporation plc 464.4M 63.0 67.0 56.0 76.0 55.0 54 84 1
Albireo Pharma, Inc. 457.1M 39.0 79.0 43.0 88.0 61.0 55 85 1
Sutro Biopharma, Inc. 420.1M 89.0 74.0 39.0 88.0 72.0 67 86 1
Aura Biosciences, Inc. 418.9M 71.0 42.0 55.0 84.0 58.0 45 87 1
MiMedx Group, Inc. 368.9M 71.0 74.0 58.0 71.0 60.0 62 88 1
Organogenesis Holdings Inc. 358.7M 68.0 67.0 64.0 64.0 55.0 57 89 1
Silence Therapeutics plc 350.0M 61.0 70.0 70.0 63.0 59.0 67 90 1
AVEO Pharmaceuticals, Inc. 337.5M 76.0 71.0 50.0 81.0 69.0 64 91 1
Aldeyra Therapeutics, Inc. 327.9M 82.0 64.0 50.0 97.0 66.0 63 92 1
Heron Therapeutics, Inc. 322.2M 62.0 79.0 37.0 74.0 99.0 73 93 1
Affimed N.V. 319.6M 66.0 60.0 67.0 56.0 52.0 60 94 1
CytoDyn Inc. 293.1M 65.0 61.0 53.0 82.0 71.0 58 95 1
Actinium Pharmaceuticals, Inc. 282.1M 58.0 76.0 39.0 80.0 74.0 62 96 1
Concert Pharmaceuticals, Inc. 231.1M 85.0 67.0 65.0 44.0 81.0 69 97 1

Income Statement Analysis

Despite a middle-of-the-road income statement report, two income statement metrics, Revenue Efficiency and Return Factors, highlighted where BioNTech SE seems to be excelling. BioNTech SE's financials reveal an interesting trend for their revenue efficiency. This characteristic can affect companies in the same industry and market capitalization by up to 12.2%. Their industry-leading revenue efficiency makes a strong case for upward pressure on its's stock price. The company's revenue efficiency, therefore, received a grade of 95. On the other hand, EBITDA, jumped out as looking rather underwhelming. BioNTech SE's management didn't make significant improvements to their EBITDA this period. In terms of the raw numbers, EBITDA was reported as 15.4B, which represents a -13.4% change from the last period. This metric might have a 29.3 percent impact on companies in the same industry and with the same market capitalization. BioNTech SE appears to be headed in the wrong direction in terms of EBITDA momentum, likely due to insufficient capital controls and a weaker than expected overall financial performance. Discouraging results like these statistically lead to negative pressure in stock prices, so we rated their EBITDA a grade of 53. the companies' income statement, therefore, earned a score of 69.

Parameter Value Change Score
EBITDA 15.4B -13.4% 53
Total Revenues 21.2B -9.1% 95
Return on Equity 105.3 -24.6% 85
* All values are TTM

The below chart describes BioNTech SE's performance as reflected on its income statement with respect to its peers. While BioNTech SE received a income statement score of 69 , the average of its peers stands on 66.

  •  BNTX
  •  Peers average
Name Market Cap Revenue Momentum Earning Movement Return Factors Momentum Income Statement mc_sort Hidden
Amgen Inc. 152.8B 84.0 76.0 71.0 81 0 1
Gilead Sciences, Inc. 110.2B 87.0 65.0 66.0 71 1 1
Vertex Pharmaceuticals Incorporated 81.2B 57.0 77.0 68.0 72 2 1
Regeneron Pharmaceuticals, Inc. 80.3B 91.0 58.0 81.0 69 3 1
Biogen Inc. 43.9B 89.0 70.0 61.0 76 4 1
Alnylam Pharmaceuticals, Inc. 27.1B 46.0 49.0 74.0 44 5 1
Horizon Therapeutics Public Limited Company 22.7B 90.0 50.0 85.0 62 6 1
Seagen Inc. 22.5B 54.0 92.0 48.0 81 7 1
BeiGene, Ltd. 19.9B 41.0 75.0 72.0 65 8 1
BioMarin Pharmaceutical Inc. 18.8B 54.0 95.0 42.0 83 9 1
Incyte Corporation 17.7B 77.0 52.0 86.0 59 10 1
United Therapeutics Corporation 12.8B 58.0 88.0 54.0 80 11 1
Neurocrine Biosciences, Inc. 12.2B 50.0 93.0 47.0 81 12 1
Sarepta Therapeutics, Inc. 10.8B 54.0 47.0 85.0 47 13 1
Halozyme Therapeutics, Inc. 7.7B 40.0 93.0 55.0 79 14 1
Ascendis Pharma A/S 6.9B 38.0 56.0 55.0 44 15 1
Ionis Pharmaceuticals, Inc. 5.8B 62.0 96.0 41.0 87 16 1
Apellis Pharmaceuticals, Inc. 5.5B 41.0 62.0 91.0 56 17 1
Exelixis, Inc. 5.5B 53.0 87.0 54.0 77 18 1
Mirati Therapeutics, Inc. 5.3B 99.0 50.0 85.0 66 19 1
Natera, Inc. 4.5B 49.0 84.0 46.0 72 20 1
Alkermes plc 4.1B 91.0 43.0 91.0 57 21 1
Cytokinetics, Incorporated 4.0B 89.0 47.0 49.0 53 22 1
Arrowhead Pharmaceuticals, Inc. 3.4B 90.0 54.0 84.0 66 23 1
PTC Therapeutics, Inc. 3.0B 43.0 86.0 76.0 77 24 1
IVERIC bio, Inc. 2.9B 81.0 54.0 53.0 57 25 1
ACADIA Pharmaceuticals Inc. 2.5B 84.0 58.0 76.0 66 26 1
Insmed Incorporated 2.5B 46.0 59.0 71.0 53 27 1
BioCryst Pharmaceuticals, Inc. 2.5B 41.0 89.0 45.0 73 28 1
Ironwood Pharmaceuticals, Inc. 1.9B 72.0 74.0 70.0 75 29 1
Agios Pharmaceuticals, Inc. 1.7B 38.0 70.0 83.0 61 30 1
Myriad Genetics, Inc. 1.6B 88.0 96.0 39.0 96 31 1
Syndax Pharmaceuticals, Inc. 1.4B 95.0 42.0 94.0 58 32 1
FibroGen, Inc. 1.4B 99.0 43.0 92.0 60 33 1
Novavax, Inc. 1.3B 38.0 79.0 59.0 66 34 1
ImmunoGen, Inc. 1.1B 50.0 47.0 90.0 45 35 1
Deciphera Pharmaceuticals, Inc. 1.1B 44.0 91.0 53.0 78 36 1
Enanta Pharmaceuticals, Inc. 910.7M 91.0 76.0 57.0 82 37 1
Geron Corporation 884.5M 42.0 60.0 79.0 53 38 1
Bicycle Therapeutics plc 859.8M 95.0 50.0 80.0 63 39 1
AnaptysBio, Inc. 785.6M 99.0 48.0 86.0 63 40 1
Anavex Life Sciences Corp. 687.6M 81.0 73.0 78.0 78 41 1
Mersana Therapeutics, Inc. 664.5M 37.0 59.0 64.0 48 42 1
bluebird bio, Inc. 645.9M 97.0 86.0 61.0 93 43 1
Intercept Pharmaceuticals, Inc. 617.5M 63.0 94.0 45.0 86 44 1
Sangamo Therapeutics, Inc. 599.8M 89.0 64.0 78.0 73 45 1
Inovio Pharmaceuticals, Inc. 509.0M 37.0 85.0 72.0 73 46 1
Anika Therapeutics, Inc. 460.8M 76.0 43.0 90.0 52 47 1
Lexicon Pharmaceuticals, Inc. 403.9M 42.0 71.0 46.0 58 48 1
MacroGenics, Inc. 395.3M 38.0 91.0 55.0 76 49 1
Precigen, Inc. 378.8M 43.0 94.0 54.0 80 50 1
Arbutus Biopharma Corporation 367.7M 48.0 70.0 55.0 61 51 1
Adaptimmune Therapeutics plc 355.5M 38.0 70.0 81.0 61 52 1
Humacyte, Inc. 321.7M 95.0 64.0 43.0 70 53 1
Acumen Pharmaceuticals, Inc. 232.5M 81.0 71.0 63.0 74 54 1
Exact Sciences Corporation 8.0B 60.0 94.0 47.0 85 55 1
Amicus Therapeutics, Inc. 3.4B 74.0 59.0 60.0 61 56 1
Xenon Pharmaceuticals Inc. 2.3B 99.0 47.0 88.0 63 57 1
Abgenix Inc. 2.1B 48.0 49.0 48.0 48 58 1
Fate Therapeutics, Inc. 2.0B 72.0 54.0 83.0 59 59 1
Veracyte, Inc. 2.0B 52.0 58.0 60.0 52 60 1
Xencor, Inc. 1.8B 64.0 82.0 54.0 77 61 1
Celldex Therapeutics, Inc. 1.7B 39.0 56.0 47.0 43 62 1
Catalyst Pharmaceuticals, Inc. 1.7B 43.0 91.0 67.0 80 63 1
Dynavax Technologies Corporation 1.6B 46.0 92.0 59.0 80 64 1
CureVac N.V. 1.4B 89.0 89.0 49.0 90 65 1
MannKind Corporation 1.2B 41.0 65.0 72.0 57 66 1
Viridian Therapeutics, Inc. 1.0B 37.0 52.0 43.0 38 67 1
Iovance Biotherapeutics, Inc. 1.0B 81.0 64.0 77.0 70 68 1
Avid Bioservices, Inc. 973.5M 55.0 54.0 91.0 59 69 1
Northwest Biotherapeutics, Inc. 864.4M 95.0 55.0 73.0 67 70 1
Agenus Inc. 823.0M 99.0 42.0 94.0 59 71 1
Immatics N.V. 803.4M 47.0 95.0 46.0 82 72 1
CTI BioPharma Corp. 763.9M 37.0 89.0 44.0 72 73 1
Aurinia Pharmaceuticals Inc. 729.0M 38.0 94.0 45.0 77 74 1
Merus N.V. 710.7M 96.0 48.0 89.0 63 75 1
CareDx, Inc 693.3M 72.0 52.0 80.0 57 76 1
ADMA Biologics, Inc. 657.2M 40.0 90.0 48.0 75 77 1
Vanda Pharmaceuticals Inc. 617.4M 89.0 45.0 90.0 58 78 1
Emergent BioSolutions Inc. 613.6M 93.0 75.0 70.0 83 79 1
Sorrento Therapeutics, Inc. 603.6M 45.0 61.0 75.0 54 80 1
Zymeworks Inc. 497.2M 94.0 81.0 80.0 90 81 1
Altimmune, Inc. 489.0M 92.0 84.0 53.0 89 82 1
Eagle Pharmaceuticals, Inc. 472.7M 46.0 96.0 40.0 81 83 1
Amarin Corporation plc 464.4M 95.0 76.0 69.0 85 84 1
Albireo Pharma, Inc. 457.1M 43.0 79.0 40.0 64 85 1
Sutro Biopharma, Inc. 420.1M 39.0 89.0 49.0 73 86 1
Aura Biosciences, Inc. 418.9M 81.0 53.0 82.0 61 87 1
MiMedx Group, Inc. 368.9M 69.0 44.0 90.0 50 88 1
Organogenesis Holdings Inc. 358.7M 74.0 52.0 87.0 58 89 1
Silence Therapeutics plc 350.0M 83.0 65.0 70.0 73 90 1
AVEO Pharmaceuticals, Inc. 337.5M 40.0 93.0 46.0 77 91 1
Aldeyra Therapeutics, Inc. 327.9M 81.0 74.0 69.0 78 92 1
Heron Therapeutics, Inc. 322.2M 59.0 81.0 61.0 76 93 1
Affimed N.V. 319.6M 95.0 48.0 74.0 64 94 1
CytoDyn Inc. 293.1M 97.0 86.0 79.0 96 95 1
Actinium Pharmaceuticals, Inc. 282.1M 81.0 71.0 59.0 74 96 1
Concert Pharmaceuticals, Inc. 231.1M 88.0 64.0 80.0 73 97 1

Cash Flow Analysis

Overall, BioNTech SE's critical cash flow metrics appear to signal strong support and a high likelihood of positive growth. BioNTech SE did a great job related to free cash flow this period, which stood at 37.0, representing a 78.5% change from the previous filing. Companies in the same industry and market capitalization are typically affected by this parameter by up to 1.0%. These free cash flow numbers show that management has executed well while generating cash flow and encouraging growth. Consequently, their free cash flow movement received a grade of 94. Also, BioNTech SE's management was effective in improving their net cash flow, which now sits at 8.4B and represents a 59.7% change from the previous report. Their net cash flow metrics are especially remarkable relative to their peers. Consequently, their net cash flow movement received a grade of 86. On the other hand, Capital Expenditure, jumped out as looking rather underwhelming. BioNTech SE's management did not a remarkable job this period managing capital expenditures (CapEx). In terms of the raw numbers, CapEx was reported as -192.4M, which represents a -30.5% change from the last period. The company's disappointing CapEx growth is expected to stunt the momentum they hoped for this period. Its CapEx movement, therefore, received a grade of 44. their cash flow, therefore, earned a score of 77.

Parameter Value Change Score
Net Cashflow 8.4B 59.7% 86
Capital Expenditure -192.4M -30.5% 44
Asset Turnover 1.4 -26.5% 44
Free Cashflow Per Share 37.0 78.5% 94
* All values are TTM

The below chart describes BioNTech SE's performance as reflected on its cash flow with respect to its peers. While BioNTech SE received a cash flow score of 77, the average of its peers stands on 67.

  •  BNTX
  •  Peers average
Name Market Cap Cashflow Momentum Free Cashflow Growth Capital Expenditure Growth Assets Factors Momentum Cash Flow mc_sort Hidden
Amgen Inc. 152.8B 81.0 79.0 82.0 50.0 79 0 1
Gilead Sciences, Inc. 110.2B 57.0 64.0 63.0 61.0 57 1 1
Vertex Pharmaceuticals Incorporated 81.2B 66.0 71.0 66.0 62.0 66 2 1
Regeneron Pharmaceuticals, Inc. 80.3B 64.0 45.0 64.0 48.0 61 3 1
Biogen Inc. 43.9B 62.0 63.0 98.0 65.0 68 4 1
Alnylam Pharmaceuticals, Inc. 27.1B 71.0 76.0 85.0 84.0 76 5 1
Horizon Therapeutics Public Limited Company 22.7B 72.0 68.0 88.0 49.0 72 6 1
Seagen Inc. 22.5B 70.0 58.0 71.0 80.0 72 7 1
BeiGene, Ltd. 19.9B 66.0 64.0 51.0 90.0 66 8 1
BioMarin Pharmaceutical Inc. 18.8B 72.0 92.0 55.0 79.0 72 9 1
Incyte Corporation 17.7B 70.0 77.0 77.0 50.0 69 10 1
United Therapeutics Corporation 12.8B 73.0 74.0 43.0 67.0 68 11 1
Neurocrine Biosciences, Inc. 12.2B 76.0 90.0 92.0 73.0 80 12 1
Sarepta Therapeutics, Inc. 10.8B 74.0 85.0 76.0 81.0 77 13 1
Halozyme Therapeutics, Inc. 7.7B 54.0 53.0 62.0 93.0 59 14 1
Ascendis Pharma A/S 6.9B 79.0 72.0 95.0 90.0 85 15 1
Ionis Pharmaceuticals, Inc. 5.8B 90.0 90.0 49.0 83.0 85 16 1
Apellis Pharmaceuticals, Inc. 5.5B 73.0 79.0 89.0 92.0 80 17 1
Exelixis, Inc. 5.5B 77.0 80.0 86.0 78.0 80 18 1
Mirati Therapeutics, Inc. 5.3B 47.0 54.0 84.0 39.0 49 19 1
Natera, Inc. 4.5B 79.0 68.0 83.0 43.0 76 20 1
Alkermes plc 4.1B 63.0 41.0 49.0 50.0 57 21 1
Cytokinetics, Incorporated 4.0B 58.0 58.0 93.0 46.0 61 22 1
Arrowhead Pharmaceuticals, Inc. 3.4B 48.0 44.0 38.0 77.0 47 23 1
PTC Therapeutics, Inc. 3.0B 87.0 74.0 72.0 93.0 89 24 1
IVERIC bio, Inc. 2.9B 68.0 59.0 42.0 70.0 64 25 1
ACADIA Pharmaceuticals Inc. 2.5B 73.0 82.0 69.0 74.0 73 26 1
Insmed Incorporated 2.5B 61.0 65.0 85.0 84.0 68 27 1
BioCryst Pharmaceuticals, Inc. 2.5B 65.0 64.0 82.0 93.0 72 28 1
Ironwood Pharmaceuticals, Inc. 1.9B 74.0 68.0 90.0 49.0 74 29 1
Agios Pharmaceuticals, Inc. 1.7B 66.0 74.0 66.0 90.0 69 30 1
Myriad Genetics, Inc. 1.6B 86.0 83.0 37.0 59.0 76 31 1
Syndax Pharmaceuticals, Inc. 1.4B 59.0 45.0 98.0 81.0 67 32 1
FibroGen, Inc. 1.4B 49.0 43.0 86.0 38.0 50 33 1
Novavax, Inc. 1.3B 79.0 81.0 50.0 96.0 78 34 1
ImmunoGen, Inc. 1.1B 64.0 58.0 41.0 88.0 63 35 1
Deciphera Pharmaceuticals, Inc. 1.1B 75.0 87.0 98.0 90.0 83 36 1
Enanta Pharmaceuticals, Inc. 910.7M 80.0 76.0 37.0 57.0 70 37 1
Geron Corporation 884.5M 59.0 68.0 46.0 88.0 60 38 1
Bicycle Therapeutics plc 859.8M 56.0 45.0 50.0 44.0 51 39 1
AnaptysBio, Inc. 785.6M 58.0 56.0 95.0 39.0 60 40 1
Anavex Life Sciences Corp. 687.6M 77.0 82.0 69.0 65.0 76 41 1
Mersana Therapeutics, Inc. 664.5M 78.0 94.0 44.0 95.0 76 42 1
bluebird bio, Inc. 645.9M 83.0 85.0 90.0 50.0 82 43 1
Intercept Pharmaceuticals, Inc. 617.5M 48.0 37.0 40.0 51.0 43 44 1
Sangamo Therapeutics, Inc. 599.8M 72.0 75.0 77.0 82.0 76 45 1
Inovio Pharmaceuticals, Inc. 509.0M 67.0 62.0 78.0 98.0 73 46 1
Anika Therapeutics, Inc. 460.8M 70.0 81.0 58.0 83.0 71 47 1
Lexicon Pharmaceuticals, Inc. 403.9M 64.0 73.0 97.0 50.0 68 48 1
MacroGenics, Inc. 395.3M 74.0 74.0 92.0 91.0 81 49 1
Precigen, Inc. 378.8M 58.0 59.0 81.0 89.0 65 50 1
Arbutus Biopharma Corporation 367.7M 75.0 72.0 48.0 78.0 72 51 1
Adaptimmune Therapeutics plc 355.5M 53.0 47.0 42.0 92.0 54 52 1
Humacyte, Inc. 321.7M 89.0 89.0 41.0 37.0 76 53 1
Acumen Pharmaceuticals, Inc. 232.5M 59.0 82.0 69.0 63.0 61 54 1
Exact Sciences Corporation 8.0B 64.0 68.0 87.0 84.0 71 55 1
Amicus Therapeutics, Inc. 3.4B 87.0 79.0 93.0 46.0 85 56 1
Xenon Pharmaceuticals Inc. 2.3B 62.0 52.0 54.0 38.0 55 57 1
Abgenix Inc. 2.1B 64.0 82.0 46.0 61.0 59 58 1
Fate Therapeutics, Inc. 2.0B 71.0 63.0 85.0 83.0 75 59 1
Veracyte, Inc. 2.0B 83.0 95.0 72.0 63.0 82 60 1
Xencor, Inc. 1.8B 79.0 94.0 40.0 80.0 74 61 1
Celldex Therapeutics, Inc. 1.7B 67.0 51.0 60.0 57.0 63 62 1
Catalyst Pharmaceuticals, Inc. 1.7B 75.0 82.0 97.0 49.0 76 63 1
Dynavax Technologies Corporation 1.6B 72.0 64.0 87.0 54.0 73 64 1
CureVac N.V. 1.4B 68.0 76.0 84.0 88.0 76 65 1
MannKind Corporation 1.2B 51.0 59.0 95.0 95.0 62 66 1
Viridian Therapeutics, Inc. 1.0B 47.0 81.0 85.0 51.0 52 67 1
Iovance Biotherapeutics, Inc. 1.0B 66.0 72.0 92.0 63.0 70 68 1
Avid Bioservices, Inc. 973.5M 81.0 67.0 62.0 67.0 79 69 1
Northwest Biotherapeutics, Inc. 864.4M 47.0 59.0 97.0 48.0 53 70 1
Agenus Inc. 823.0M 57.0 38.0 89.0 37.0 57 71 1
Immatics N.V. 803.4M 75.0 97.0 86.0 56.0 78 72 1
CTI BioPharma Corp. 763.9M 86.0 81.0 69.0 92.0 87 73 1
Aurinia Pharmaceuticals Inc. 729.0M 81.0 86.0 37.0 91.0 77 74 1
Merus N.V. 710.7M 70.0 69.0 69.0 45.0 66 75 1
CareDx, Inc 693.3M 55.0 52.0 60.0 73.0 56 76 1
ADMA Biologics, Inc. 657.2M 77.0 78.0 61.0 87.0 77 77 1
Vanda Pharmaceuticals Inc. 617.4M 85.0 77.0 42.0 52.0 75 78 1
Emergent BioSolutions Inc. 613.6M 56.0 38.0 89.0 50.0 58 79 1
Sorrento Therapeutics, Inc. 603.6M 66.0 84.0 45.0 86.0 65 80 1
Zymeworks Inc. 497.2M 69.0 66.0 92.0 89.0 77 81 1
Altimmune, Inc. 489.0M 72.0 78.0 76.0 52.0 71 82 1
Eagle Pharmaceuticals, Inc. 472.7M 52.0 46.0 74.0 86.0 58 83 1
Amarin Corporation plc 464.4M 60.0 62.0 69.0 51.0 59 84 1
Albireo Pharma, Inc. 457.1M 56.0 67.0 86.0 48.0 59 85 1
Sutro Biopharma, Inc. 420.1M 74.0 95.0 95.0 89.0 82 86 1
Aura Biosciences, Inc. 418.9M 62.0 87.0 92.0 63.0 68 87 1
MiMedx Group, Inc. 368.9M 53.0 46.0 87.0 76.0 59 88 1
Organogenesis Holdings Inc. 358.7M 63.0 43.0 89.0 60.0 66 89 1
Silence Therapeutics plc 350.0M 67.0 65.0 72.0 68.0 69 90 1
AVEO Pharmaceuticals, Inc. 337.5M 72.0 88.0 69.0 88.0 75 91 1
Aldeyra Therapeutics, Inc. 327.9M 58.0 61.0 69.0 63.0 59 92 1
Heron Therapeutics, Inc. 322.2M 69.0 81.0 97.0 91.0 78 93 1
Affimed N.V. 319.6M 70.0 57.0 95.0 43.0 75 94 1
CytoDyn Inc. 293.1M 74.0 90.0 98.0 77.0 81 95 1
Actinium Pharmaceuticals, Inc. 282.1M 72.0 72.0 69.0 70.0 72 96 1
Concert Pharmaceuticals, Inc. 231.1M 68.0 74.0 72.0 84.0 72 97 1

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