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Novavax, Inc. (NVAX) Report Analysis

Corporate Events

Positive

Novavax, Inc. Presents Data At FDA VRBPAC Meeti...

2022-06-28 22:41:00

Novavax, Inc. participated in the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee's (VRBPAC) mee...

Positive

Novavax' Nuvaxovid Covid-19 Vaccine Receives Em...

2022-06-23 20:56:00

Novavax, Inc. announced that the Taiwan Food and Drug Administration has granted emergency use authorization (EUA) for Nuvaxovid (NVX-CoV2373)...

Positive

Novavax, Inc. Covid-19 Vaccine Nuvaxovid™ Recom...

2022-06-23 18:39:00

Novavax, Inc. announced that the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorizati...

Positive

Novavax, Inc. Announces Australian Therapeutic ...

2022-06-13 11:00:00

Novavax, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid(TM) (NVX-...

Positive

Novavax, Inc. Announces FDA Advisory Committee ...

2022-06-07 22:00:00

Novavax, Inc. announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted...

Neutral

Novavax, Inc. Presents at DIA Global Annual Mee...

2022-05-28 18:13:00

Novavax, Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022 . Venue: Chicago, Illinois, United States. Speakers: Greg Ball, Head of ...

Neutral

Novavax, Inc. Presents at BIO International Con...

2022-05-15 00:00:00

Novavax, Inc. Presents at BIO International Convention 2022, Jun-13-2022 . Venue: San Diego Convention Center, San Diego, California, United S...

Neutral

Novavax, Inc. Presents at Bank of America 2022 ...

2022-05-04 20:02:00

Novavax, Inc. Presents at Bank of America 2022 Healthcare Conference, May-11-2022 05:20 PM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las V...

Neutral

Novavax, Inc., Q1 2022 Earnings Call, May 09, 2022

2022-05-03 06:59:00

Novavax, Inc., Q1 2022 Earnings Call, May 09, 2022

Neutral

Novavax, Inc. to Report Q1, 2022 Results on May...

2022-05-03 06:59:00

Novavax, Inc. announced that they will report Q1, 2022 results After-Market on May 09, 2022

Neutral

Novavax, Inc., Annual General Meeting, Jun 16, 2022

2022-05-02 21:02:00

Novavax, Inc., Annual General Meeting, Jun 16, 2022, at 08:30 US Eastern Standard Time. Agenda: To consider the election of two directors as C...

Neutral

Novavax, Inc. - Shareholder/Analyst Call

2022-05-02 21:02:00

Annual Meeting of Stockholders

Neutral

Novavax, Inc. Proposes Amendment and Restatemen...

2022-05-02 21:02:00

Novavax, Inc. proposed amendment and restatement of the By-laws to permit stockholder access to the company’s proxy statement with respect to ...

Positive

FDA Announces Vaccines and Related Biological P...

2022-04-29 15:07:00

Novavax, Inc. announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC...

Positive

Novavax Announces Initiation of COVID-19 Vaccin...

2022-04-22 11:00:00

Novavax, Inc. has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the ped...

Positive

Initial Results from Novavax' COVID-19-Influenz...

2022-04-20 16:41:00

Novavax, Inc. announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines N...

Neutral

Novavax, Inc. Presents at 32nd European Congres...

2022-04-18 13:43:00

Novavax, Inc. Presents at 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr-23-2022 . Venue: Lisbon, Portugal.

Positive

Novavax to Provide a First Look at Data from It...

2022-04-18 13:35:00

Novavax, Inc. will provide a first look at data from its COVID-19 influenza combination vaccine and seasonal influenza vaccine trials, at the ...

Neutral

Novavax, Inc. Presents at World Vaccine Congres...

2022-04-16 13:52:00

Novavax, Inc. Presents at World Vaccine Congress 2022, Apr-18-2022 through Apr-22-2022. Venue: Marriott Marquis Washington, Washington , Distr...

Positive

Swissmedic Grants Conditional Marketing Authori...

2022-04-13 10:00:00

Novavax, Inc. announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (C...

Positive

Novavax, Inc. Submits Request to Expand Conditi...

2022-03-31 10:00:00

Novavax, Inc. announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid™ COVID-19 Vaccine (reco...

Neutral

European Society of Clinical Microbiology and I...

2022-03-31 06:00:00

European Society of Clinical Microbiology and Infectious Diseases, 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr ...

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

Novavax, Inc. - Special Call

2022-02-10 21:30:00

Novavax, Inc. - Special Call

Positive

Novavax, Inc. Announces Positive Results of COV...

2022-02-10 21:12:00

Novavax, Inc. announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endp...

Positive

Medicines and Healthcare Products Regulatory Ag...

2022-02-03 12:22:00

Novavax, Inc. announced that the Medicines and Healthcare products Rbegulatory Agency (MHRA) has granted conditional marketing authorization (...

Positive

Novavax, Inc. Submits Request to the U.S. FDA f...

2022-01-31 18:42:00

Novavax, Inc. announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) fo...

Neutral

Novavax, Inc. and Israel Announce Advance Purch...

2022-01-28 13:00:00

Novavax, Inc. and Israel's Ministry of Health announced an agreement for the purchase of NVX-CoV2373, the company's recombinant nanoparticle p...

Neutral

Terrapinn Holdings Ltd, World Vaccine Congress ...

2022-01-27 09:13:00

Terrapinn Holdings Ltd, World Vaccine Congress 2022, Apr 18, 2022 through Apr 22, 2022. Venue: Marriott Marquis Washington, Washington , Distr...

Positive

Novavax, Inc. Submits Final Data Packages to U....

2021-12-31 17:15:00

Novavax, Inc. announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and contro...

Neutral

Novavax, Inc. Enters into Amendment to Its Coll...

2021-12-30 22:17:00

On December 23, 2021, Novavax, Inc. entered into an amendment to its collaboration and license agreement with SK bioscience Co. Ltd., dated Fe...

Positive

Novavax and Serum Institute of India Receive Em...

2021-12-28 14:29:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Drugs Controller General of India (DCGI) has granted emergency use aut...

Neutral

Novavax, Inc. and SK bioscience Co. Limited Exp...

2021-12-23 23:30:00

Novavax, Inc. and SK bioscience Co. Limited announced the expansion of the companies' collaboration and license agreements for NVX-CoV2373, No...

Neutral

Novavax, Inc. - Special Call

2021-12-22 21:02:00

To discuss Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies

Positive

Novavax, Inc. Announces Initial Omicron Cross-R...

2021-12-22 21:02:00

Novavax, Inc. announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well ...

Positive

Novavax, Inc. Announces Initiation of PREVENT-1...

2021-12-21 22:01:00

Novavax, Inc. announced that the first booster doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine wit...

Positive

Novavax, Inc. Announces European Commission Gra...

2021-12-20 16:21:00

Novavax, Inc. announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19...

Positive

Novavax, Inc. Files for Emergency Use of COVID-...

2021-12-13 11:30:00

Novavax, Inc. announced that it has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its CO...

Neutral

Drug Information Association, Inc., DIA Global ...

2021-12-10 06:32:00

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022. Venue: Chicago, Illinois, United States.

Negative

The Law Offices of Frank R. Cruz Announces the ...

2021-12-02 16:35:00

The Law Offices of Frank R. Cruz announced that a class action lawsuit has been filed on behalf of persons and entities that purchased or othe...

Positive

Novavax, Inc. Announces Submission to the Singa...

2021-11-24 14:15:00

Novavax, Inc. announced its submission to the Singapore Health Sciences Authority (HSA) for interim authorization of its COVID-19 vaccine unde...

Neutral

Novavax, Inc. Presents at 4th Annual Evercore I...

2021-11-23 14:15:00

Novavax, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-02-2021 09:15 AM. Speakers: Gregory M. Glenn, President o...

Positive

Novavax Confirms European Medicines Agency Revi...

2021-11-17 16:25:00

Novavax, Inc. announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorizatio...

Positive

Novavax and Serum Institute of India Receive Em...

2021-11-17 14:29:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Philippine Food and Drug Administration (FDA) has granted emergency us...

Positive

Novavax Announces Submission of Biologics Licen...

2021-11-15 13:45:00

Novavax, Inc. announced the submission of a Biologics License Application (BLA) for Novavax' COVID-19 vaccine to South Korea'sMinistry of Food...

Negative

Pomerantz Law Firm Announces the Filing of Clas...

2021-11-13 04:38:00

Pomerantz LLP announced that a class action lawsuit has been filed against Novavax, Inc. and certain of its officers. The class action, filed ...

Neutral

Biotechnology Innovation Organization, BIO Inte...

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Cente...

Neutral

Biotechnology Innovation Organization, BIO Inte...

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Cente...

Negative

Novavax, Inc Announces Executive Appointments

2021-11-04 20:02:00

Novavax, Inc. Announced at the promotions of Jim Kelly as Executive Vice President, Chief Financial Officer and Treasurer Denny Kim, M.D. as S...

Positive

Novavax Files Covid-19 Vaccine for Provisional ...

2021-11-03 13:52:00

Novavax, Inc. announced the company has filed for provisional approval of the vaccine to the New Zealand Medicines and Medical Devices Safety ...

Positive

Novavax and Serum Institute of India Receive Em...

2021-11-01 10:47:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) announced that the National Agency of Drug and Food Control of the Republic of Indo...

Positive

Novavax Files for COVID-19 Vaccine Authorizatio...

2021-11-01 10:20:00

Novavax, Inc. announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the fir...

Neutral

SVB Leerink LLC, 11th SVB Leerink Annual Global...

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, Unit...

Positive

Novavax, Inc. Files for Provisional Approval of...

2021-10-29 11:15:00

Novavax, Inc. announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its...

Positive

Novavax, Inc. Files for Authorization of its CO...

2021-10-27 15:09:00

Novavax, Inc. announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (M...

Neutral

Novavax, Inc., Q3 2021 Earnings Call, Nov 04, 2021

2021-10-18 13:15:00

Novavax, Inc., Q3 2021 Earnings Call, Nov 04, 2021

Neutral

Novavax, Inc. to Report Q3, 2021 Results on Nov...

2021-10-18 13:15:00

Novavax, Inc. announced that they will report Q3, 2021 results After-Market on Nov 04, 2021

Negative

Novavax, Inc. Announces Executive Appointments

2021-10-04 20:05:00

Novavax, Inc. announced the appointment of Denny Kim, M.D., MPH to the newly created role of Senior Vice President, Chief Safety Officer and H...

Positive

Novavax, Inc. Announces Results from Novavax Na...

2021-09-24 00:03:00

Novavax, Inc. announced publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent season...

Positive

Novavax, Inc. and Serum Institute of India Pvt....

2021-09-23 13:25:00

Novavax, Inc. with its partner, Serum Institute of India Pvt. Ltd. announced a regulatory submission to the World Health Organization for emer...

Neutral

Novavax, Inc. Presents at Cantor Global Healthc...

2021-09-23 13:15:00

Novavax, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-29-2021 08:40 AM. Venue: New York, United States. Speakers: Gregory M....

Neutral

Novavax, Inc. - Special Call

2021-09-20 20:05:00

To discuss on Novavax' COVID-19 vaccine candidate, NVX-CoV2373 along with fostering global vaccine access

Neutral

Novavax, Inc. Presents at Morgan Stanley 19th A...

2021-09-09 13:54:00

Novavax, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-10-2021 02:00 PM. Venue: New Windsor, United States. Sp...

Neutral

Novavax, Inc. Presents at H.C. Wainwright 23rd ...

2021-09-09 13:25:00

Novavax, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-12-2021 through Sep-16-2021. Venue: Lotte New York Pal...

Positive

Novavax, Inc. Initiates Phase 1/2 Clinical Tria...

2021-09-08 12:23:00

Novavax, Inc. announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination v...

Neutral

Novavax, Inc. Presents at Citi’s 16th Annual Bi...

2021-09-07 08:49:00

Novavax, Inc. Presents at Citi’s 16th Annual BioPharma Virtual Conference, Sep-09-2021 04:10 PM. Venue: New York, United States. Speakers: Gre...

Neutral

Evercore Inc., 4th Annual Evercore ISI HealthCO...

2021-08-24 20:29:00

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021.

Negative

Novavax, Inc. Announces Executive Appointments

2021-08-17 15:26:00

Novavax, Inc. announced the appointment of Jim Kelly as Executive Vice President, and Treasurer, and Nasir Egal, Ph.D. as Senior Vice Presiden...

Negative

Novavax, Inc. Appoints Jim Kelly as Chief Finan...

2021-08-16 12:50:00

Novavax, Inc. announced the appointment of Jim Kelly as Executive Vice President, Chief Financial Officer (CFO) and Treasurer. Mr. Kelly will ...

Positive

Novavax, Inc. Announces Covid-19 Vaccine Booste...

2021-08-05 20:04:00

Novavax, Inc. announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vacci...

Positive

Novavax and Serum Institute of India Announces ...

2021-08-05 20:03:00

Novavax, Inc. with its partner, Serum Institute of India Pvt. Ltd. announced that the companies have filed regulatory submissions for emergenc...

Neutral

Novavax, Inc. has filed a Shelf Registration in...

2021-08-05 00:00:00

Novavax, Inc. has filed a Shelf Registration in the amount of $335.715 million. Security Name: Common Stock Securities Offered: 1,500,000 ...

Neutral

Novavax and European Commission Finalize Advanc...

2021-08-04 13:10:00

Novavax, Inc. announced that it has reached an agreement with the European Commission (EC) for the purchase of up to 200 million doses of NVX-...

Neutral

Novavax, Inc. to Report Q2, 2021 Results on Aug...

2021-07-06 12:30:00

Novavax, Inc. announced that they will report Q2, 2021 results After-Market on Aug 05, 2021

Neutral

Novavax, Inc., Q2 2021 Earnings Call, Aug 05, 2021

2021-07-06 12:30:00

Novavax, Inc., Q2 2021 Earnings Call, Aug 05, 2021

Positive

Novavax, Inc. Publishes Results of United Kingd...

2021-06-30 21:26:00

Novavax, Inc. announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candida...

Positive

Novavax, Inc. Presents Data At FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific Variants

2022-06-28 22:41:00

Novavax, Inc. participated in the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting which resulted in a 19-2 vote to recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning this fall. During the meeting, Novavaxhighlighted data showing that the structural features of Novavax' protein-based COVID-19 vaccine, enhanced by the Matrix-M™ adjuvant, displayed epitopes across both the original strain and emerging variants, contributing to the generation of broadly cross-reacting antibodies. Additional data from Phase 2 and Phase 3 trials, as well as in vitro data on neutralizing antibodies and receptor inhibition from trial participants, show cross-reactivity with all variants tested, particularly following booster doses. Novavax presented preclinical trial data showing that boosting with either the prototype (NVX-CoV2373), Omicron BA.1 (NVX-CoV2515), or bivalent vaccine generated antibody levels that were consistent with dosing regimens in the Phase 3 clinical trials. While boosting with the prototype covers all strains, providing an Omicron booster enhances immunity to related Omicron sub-variants. Boosting with a bivalent vaccine containing prototype and Omicron BA.1 showed no advantages in any of the responses compared to boosting with BA.1 alone. A clinical trial is ongoing with results anticipated in September and product availability expected in fourth quarter. Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) in January 2022. The VRBPAC Committee voted 21 to 0 with one abstention on June 7, 2022, to recommend that the FDA grant EUA for NVX-CoV2373 for individuals aged 18 years and over. The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

Positive

Novavax' Nuvaxovid Covid-19 Vaccine Receives Emergency Use Authorization in Taiwan for Use in Individuals Aged 18 and over

2022-06-23 20:56:00

Novavax, Inc. announced that the Taiwan Food and Drug Administration has granted emergency use authorization (EUA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in individuals aged 18 years and over. Novavax and Taiwan have executed a supply agreement and the doses for Taiwan would represent the first shipment of Nuvaxovid to a country participating under the COVAX Facility. COVAX was established to allocate and distribute vaccines equitably to participating countries and economies. The EUA was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a UK-based trial with almost 15,000 adult participants, also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. The Coalition for Epidemic Preparedness Innovations has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up around the globe. Nuvaxovid has received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization.

Positive

Novavax, Inc. Covid-19 Vaccine Nuvaxovid™ Recommends for Expanded Conditional Marketing Authorization in the European Union by Chmp for Adolescents Aged 12 Through 17

2022-06-23 18:39:00

Novavax, Inc. announced that the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its opinion on results from the Phase 3 PREVENT-19 clinical trial. The CHMP recommendation was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. Fever was seen more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days from the vaccination. The European Commission (EC) granted CMA for Nuvaxovid to prevent COVID-19 in people 18 years of age and over in December 2021. In the 12 through 17 year-old population, emergency use authorization has been granted in India.

Positive

Novavax, Inc. Announces Australian Therapeutic Goods Administration (TGA) Grants Provisional Registration of Nuvaxovid(TM) (NVX-CoV2373) COVID-19 Covid-19 Vaccine as A Booster in Individuals Aged 18 and over

2022-06-13 11:00:00

Novavax, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid(TM) (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. The provisional registration was based on data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose. In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups. The TGA granted provisional registration in January 2022 for use of Nuvaxovid in individuals aged 18 and over. Novavax filed for expanded provisional registration in Australia for use in adolescents aged 12 through 17 in May 2022.Novavax' sponsor in Australia is Biocelect Pty. Ltd. Authorization in the U.S. The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid(TM) has not yet been approved by the U.S. Food and Drug Administration.

Positive

Novavax, Inc. Announces FDA Advisory Committee Recommends Emergency Use Authorization of Novavax Covid-19 Vaccine for People Aged 18 Years and Older

2022-06-07 22:00:00

Novavax, Inc. announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over. The VRBPAC considered data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine. In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy (95% confidence interval [CI], 82.9 to 94.6; P<0.001) with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during the trial (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. The data showed that overall the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%) and in the post-crossover portions of Novavax trials the observed cases were all within the expected rate. The FDA considers the recommendations of VRBPAC when making decisions on EUA. The Novavax COVID-19 vaccine has received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization. The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's large vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain. NVX-CoV2373 continues being evaluated in two pivotal Phase 3 trials. PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, NVX-CoV2373 achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S. Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement (# MCDC2011-001). Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Novavax, Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022

2022-05-28 18:13:00

Novavax, Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022 . Venue: Chicago, Illinois, United States. Speakers: Greg Ball, Head of Safety Statistics.

Neutral

Novavax, Inc. Presents at BIO International Convention 2022, Jun-13-2022

2022-05-15 00:00:00

Novavax, Inc. Presents at BIO International Convention 2022, Jun-13-2022 . Venue: San Diego Convention Center, San Diego, California, United States. Speakers: John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Neutral

Novavax, Inc. Presents at Bank of America 2022 Healthcare Conference, May-11-2022 05:20 PM

2022-05-04 20:02:00

Novavax, Inc. Presents at Bank of America 2022 Healthcare Conference, May-11-2022 05:20 PM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Neutral

Novavax, Inc., Q1 2022 Earnings Call, May 09, 2022

2022-05-03 06:59:00

Novavax, Inc., Q1 2022 Earnings Call, May 09, 2022

Neutral

Novavax, Inc. to Report Q1, 2022 Results on May 09, 2022

2022-05-03 06:59:00

Novavax, Inc. announced that they will report Q1, 2022 results After-Market on May 09, 2022

Neutral

Novavax, Inc., Annual General Meeting, Jun 16, 2022

2022-05-02 21:02:00

Novavax, Inc., Annual General Meeting, Jun 16, 2022, at 08:30 US Eastern Standard Time. Agenda: To consider the election of two directors as Class III directors to serve on the board of directors, each for a three-year term expiring at the 2025 Annual Meeting of Stockholders; to consider the advisory vote to approve the compensation of Named Executive Officers; to consider the amendment and restatement of the Second Amended and Restated Certificate of Incorporation of Novavax, Inc., as amended (the “Certificate of Incorporation”) to eliminate the supermajority voting provisions; to consider the amendment and restatement of the Amended and Restated By-laws of Novavax, Inc. (the “By-laws”) to eliminate the supermajority voting provisions; to consider the amendment and restatement of the By-laws to permit stockholder access to the Company’s proxy statement with respect to the nomination of directors; and to consider the other resolutions.

Neutral

Novavax, Inc. - Shareholder/Analyst Call

2022-05-02 21:02:00

Annual Meeting of Stockholders

Neutral

Novavax, Inc. Proposes Amendment and Restatement of the By-Laws

2022-05-02 21:02:00

Novavax, Inc. proposed amendment and restatement of the By-laws to permit stockholder access to the company’s proxy statement with respect to the nomination of directors at its AGM to be held on June 16, 2022.

Positive

FDA Announces Vaccines and Related Biological Products Advisory Committee Review of Novavax' COVID-19 Vaccine

2022-04-29 15:07:00

Novavax, Inc. announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review NVX-CoV2373 COVID-19 Vaccine (recombinant, adjuvanted) for active immunization against SARS-CoV-2 at a meeting scheduled for June 7, 2022. VRBPAC reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases. Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) for NVX-CoV2373 in January 2022 based on the totality of pre-clinical, clinical, and manufacturing-related data provided to the agency.

Positive

Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial

2022-04-22 11:00:00

Novavax, Inc. has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17. All PREVENT-19 trial participants aged 12 through 17 are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.

Positive

Initial Results from Novavax' COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

2022-04-20 16:41:00

Novavax, Inc. announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic. The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine. The study employed descriptive endpoints, assessing safety and the immunological responses of different CIC vaccine formulations. A Design of Experiments (DOE) modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery. Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. These data support advancement to a Phase 2 confirmation trial, expected to begin by the end of 2022. Data from the trial were presented at the World Vaccine Congress (WVC) in Washington, DC.

Neutral

Novavax, Inc. Presents at 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr-23-2022

2022-04-18 13:43:00

Novavax, Inc. Presents at 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr-23-2022 . Venue: Lisbon, Portugal.

Positive

Novavax to Provide a First Look at Data from Its Covid-19 Influenza Combination Vaccine and Seasonal Influenza Vaccine Trials

2022-04-18 13:35:00

Novavax, Inc. will provide a first look at data from its COVID-19 influenza combination vaccine and seasonal influenza vaccine trials, at the World Vaccine Congress (WVC) in Washington, DC, April 18 - 21, 2022. In addition, the latest data on its protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be presented at both WVC and the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, Portugal, April 23 - 26, 2022. Data from eight abstracts and presentations, including four oral presentations, will be presented across the two congresses.

Neutral

Novavax, Inc. Presents at World Vaccine Congress 2022, Apr-18-2022 through Apr-22-2022

2022-04-16 13:52:00

Novavax, Inc. Presents at World Vaccine Congress 2022, Apr-18-2022 through Apr-22-2022. Venue: Marriott Marquis Washington, Washington , District Of Columbia, United States. Presentation Date & Speakers: Apr-19-2022, Gregory M. Glenn, President of Research & Development. Apr-20-2022, Gregory M. Glenn, President of Research & Development.

Positive

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

2022-04-13 10:00:00

Novavax, Inc. announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Switzerland. The Swissmedic decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. Novavax previously announced an agreement with the government of Switzerland for up to six million doses of Novavax' COVID-19 vaccine.

Positive

Novavax, Inc. Submits Request to Expand Conditional Marketing Authorization of COVID-19 Vaccine in the European Union to Adolescents (Ages 12-17)

2022-03-31 10:00:00

Novavax, Inc. announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) in the European Union (EU) to adolescents aged 12 through 17 years. The submission includes clinical data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Novavax' COVID-19 vaccine. The vaccine, also known as NVX-CoV2373, achieved its primary effectiveness endpoint in the trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. Additionally, preliminary safety data from the pediatric expansion of PREVENT-19 showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. The submission builds on Novavax' efforts to expand authorizations of its COVID-19 vaccine to younger populations. The Drugs Controller General of India recently approved NVX-CoV2373 for restricted use in emergency situation for adolescents aged 12 through 17 years in India. SK bioscience, Novavax' licensee in South Korea, also recently submitted a regulatory filing for adolescent authorization of the vaccine to the Korean Ministry of Food and Drug Safety. Novavax expects to initiate rolling submissions of regulatory filings in this age group to additional regulatory authorities worldwide and to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

Neutral

European Society of Clinical Microbiology and Infectious Diseases, 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr 23, 2022 through Apr 26, 2022

2022-03-31 06:00:00

European Society of Clinical Microbiology and Infectious Diseases, 32nd European Congress of Clinical Microbiology & Infectious Diseases, Apr 23, 2022 through Apr 26, 2022. Venue: Lisbon, Portugal.

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

Novavax, Inc. - Special Call

2022-02-10 21:30:00

Novavax, Inc. - Special Call

Positive

Novavax, Inc. Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial

2022-02-10 21:12:00

Novavax, Inc. announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. The study enrolled 2,247 adolescents aged 12 through 17-years across 73 sites in the U.S. to evaluate safety, effectiveness (immunogenicity), and efficacy, with an emphasis on ensuring well balanced racial and ethnic representation among participants. The primary PREVENT-19 pivotal Phase 3 trial conducted in adults aged 18 years and older, results of which were published in The New England Journal of Medicine (NEJM), enrolled approximately 30,000 participants in the U.S. and Mexico. NVX-CoV2373 achieved 90.4% efficacy overall and demonstrated a reassuring safety and tolerability profile. Serious and severe adverse events in adults were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed in adults during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, for both the primary PREVENT-19 trial and the pediatric expansion, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. NVX-CoV2373 has not yet been authorized in the adolescent population. Novavax expects to submit its regulatory filings for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities during the first quarter of 2022. Novavax also expects to initiate additional studies globally evaluating younger age groups during the second quarter of 2022. To date, NVX-CoV2373 has received authorization from multiple regulatory authorities globally, including conditional marketing authorization from the European Commission, the Medicines and Healthcare products Regulatory Agency, and emergency use listing (EUL) from the World Health Organization (WHO). With WHO EUL, there is the opportunity for authorization in over 170 countries with a potential reach of over six billion lives. The vaccine is also currently under review by multiple regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA). Results:Clinical efficacy consistent between adolescent and adult participants: In the placebo-controlled, observer-blinded study, adolescent participants were randomized 2:1 to receive active vaccine or placebo. Study participants underwent blinded crossover to alternate study material after the required safety data were collected to ensure that all participants received active vaccine. During the period of placebo-controlled observation, NVX-CoV2373 demonstrated overall protective efficacy of 79.5% (95% CI: 46.8, 92.1) against COVID-19. Efficacy was consistent across age groups and all cases observed in the vaccine group were mild as defined by the trial protocol. Efficacy endpoints were accrued from May 24 through September 27, 2021 – a time when the Delta variant was the predominant strain in the U.S., showing high transmission and high severity of disease. Sequence data are available for 11 of the 20 confirmed cases, 100% of which were determined to be caused by the Delta variant. Vaccine efficacy against the Delta variant was 82.0% (95% CI: 32.4, 95.2). Results: Consistent response to variants: Data from the pediatric expansion of PREVENT-19 showed in post hoc analyses robust immune responses in adolescents, including IgG responses against Spike proteins of several variants (including Alpha, Beta, Delta, Gamma, Mu, and Omicron) that were 2-3-fold higher than in adults, with 100% seroconversion against all variants following a 2-dose series of vaccinations. Adolescent functional immune responses (hACE2 receptor inhibition) against these variants were 2.4-4-fold higher than in adults against all evaluated variants.

Positive

Medicines and Healthcare Products Regulatory Agency Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine in Great Britain

2022-02-03 12:22:00

Novavax, Inc. announced that the Medicines and Healthcare products Rbegulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older in Great Britain. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Great Britain. The MHRA decision was based on the totality of preclinical, clinical, and chemistry, manufacturing and controls (CMC) data reviewed by the agency. This includes two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in theNew England Journal of Medicine (NEJM)i; and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJMii. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. The vaccine is stored at 2° - 8° Celsius and has a current assigned shelf life in Great Britain of 9 months. Novavax previously announced an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of Novavax' COVID-19 vaccine.

Positive

Novavax, Inc. Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

2022-01-31 18:42:00

Novavax, Inc. announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2. The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90% and a reassuring safety profile. Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and published results in theNew England Journal of Medicine (NEJM) and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed in authorized markets. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17. NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and emergency use listing (EUL) from the World Health Organization (WHO), with additional filings currently under review. NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII). They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

Neutral

Novavax, Inc. and Israel Announce Advance Purchase Agreement for Supply of COVID-19 Vaccine

2022-01-28 13:00:00

Novavax, Inc. and Israel's Ministry of Health announced an agreement for the purchase of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. Under the advance purchase agreement, Novavax will provide an initial 5 million doses of its protein-based vaccine with an option for Israel to purchase an additional 5 million doses. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval. Novavax is conducting two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in theNew England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated high efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common =1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. Novavax received conditional marketing authorization for NVX-CoV2373 in the European Union and emergency use listing (EUL) from the World Health Organization (WHO), among others. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company submitted its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021 and expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines. NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's large vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials. PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Terrapinn Holdings Ltd, World Vaccine Congress 2022, Apr 18, 2022 through Apr 22, 2022

2022-01-27 09:13:00

Terrapinn Holdings Ltd, World Vaccine Congress 2022, Apr 18, 2022 through Apr 22, 2022. Venue: Marriott Marquis Washington, Washington , District Of Columbia, United States.

Positive

Novavax, Inc. Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine

2021-12-31 17:15:00

Novavax, Inc. announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines. Novavax has filed the complete CMC data package, which leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), vaccine manufacturer by volume, with the FDA. The company expects to later supplement the submission with data from additional manufacturing sites across Novavax' global supply chain. About NVX-CoV2373:- NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. The current assigned shelf life of the vaccine is 9 months.

Neutral

Novavax, Inc. Enters into Amendment to Its Collaboration and License Agreement with Sk Bioscience Co., Ltd

2021-12-30 22:17:00

On December 23, 2021, Novavax, Inc. entered into an amendment to its collaboration and license agreement with SK bioscience Co. Ltd., dated February 12, 2021, under which SK bioscience was granted an exclusive license to develop, manufacture and commercialize NVX-CoV2373, the Company’s vaccine candidate for the SARS-CoV-2 virus (the “Vaccine Product”) in the Republic of Korea, including the anticipated sale of 40 million doses to the government of the Republic of Korea, under an advance purchase agreement (the “First Korean APA”). On December 23, 2021, the Company also entered into Statement of Work No. 1 (the “Statement of Work”) to the Collaboration and License Agreement. SK bioscience agreed to reserve and use additional capacity of an SK bioscience manufacturing facility for the manufacture of the protein antigen component (the “Collaboration Antigen Product”) of the Vaccine Product through 2022, with an exclusive option valid for a certain given period for the Company to negotiate the extension of such capacity into 2023. In addition, SK bioscience agreed to purchase sufficient doses of the Company’s Matrix-M™ adjuvant to manufacture, in addition to the 40 million doses of finished Vaccine Product under the First Korean APA, the additional doses of finished Vaccine Product that SK bioscience may sell to the governments of the Republic of Korea, Thailand, and Vietnam pursuant to the advance purchase agreements. The Amendment provides that the Collaboration and License Agreement will expire upon the later of (i) February 12, 2041, (ii) the completion of both parties’ duties and obligations under the Collaboration and License Agreement and any advance purchase agreements with the governments of Korea, Thailand, and Vietnam, or (iii) the day that the World Health Organization declares that there is no longer a COVID-19 pandemic; provided, however, that the non-exclusive license to distribute, offer for sale, and sell the Vaccine Product to the governments of Thailand and Vietnam shall expire on February 12, 2026, or earlier on March 31, 2022 with respect to either Thailand or Vietnam, or both countries, if SK bioscience has not executed an advance purchase agreement with such country(ies) by March 31, 2022. However, in the event SK bioscience sells a competing vaccine product for the prevention of COVID-19 in Korea, the exclusive license will convert to a non-exclusive license solely to allow SK bio to sell to the government of the Republic of Korea and will expire on the later of February 12, 2024 or the first anniversary of such sale, and in the event SK bioscience sells a competing vaccine product for the prevention of COVID-19 in Thailand or Vietnam, the non-exclusive license will expire on the earlier of the first anniversary of such sale or February 12, 2026.

Positive

Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India

2021-12-28 14:29:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax™. Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas. The Novavax/SII vaccine recently received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings in South Korea and Japan, respectively. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

Neutral

Novavax, Inc. and SK bioscience Co. Limited Expands Manufacturing Agreement

2021-12-23 23:30:00

Novavax, Inc. and SK bioscience Co. Limited announced the expansion of the companies' collaboration and license agreements for NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine. The companies have agreed that SK bioscience will reserve significant additional manufacturing capacity to produce antigen, a key component of NVX-CoV2373, through 2022, with the possibility to extend the arrangement. The agreement between the companies also builds on a previously announced advance purchase agreement (APA) between SK bioscience and the Korean government to supply 40 million doses of NVX-CoV2373 for the Republic of Korea. SK bioscience may supply additional quantities of NVX-CoV2373 in the Korean market in 2022. Additionally, SK bioscience has acquired non-exclusive rights to sell doses of Novavax' vaccine to the governments of Thailand and Vietnam. In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 with South Korea's Ministry of Food and Drug Safety (MFDS) in April. A biologics license application was submitted to the MFDS in November.

Neutral

Novavax, Inc. - Special Call

2021-12-22 21:02:00

To discuss Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies

Positive

Novavax, Inc. Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies

2021-12-22 21:02:00

Novavax, Inc. announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months. Immune responses included the following: Anti-spike IgG titers after Dose 3 increased 5.4-fold (prototype) to 9.3-fold (Omicron) from peak responses seen after 2-dose primary vaccination. This represents a 61.1-fold (prototype) and a 73.5-fold (Omicron) increase from prior to the Dose 3 boost. ACE2-inhibition titers increased 6-fold (prototype) to 19.9-fold (Omicron) compared to peak responses following 2-dose primary series, representing a 54.4-fold (prototype), a 24.4-fold (Delta) and a 36.3-fold (Omicron) increase from prior to the booster. Wild-type neutralization responses were observed after 2 doses for prototype, Delta and Omicron. Significant increases were observed after boosting, with titers for Delta and Omicron comparable to levels associated with protection in U.S. and Mexico and U.K. Phase 3 studies. After 2 doses, Omicron wild-type neutralization was <4-fold lower than prototype, suggesting that both a booster dose as well as an Omicron-specific vaccine may be beneficial. Further, data from the pediatric expansion of Novavax' PREVENT-19 Phase 3 trial in the U.S. and Mexico showed robust immune responses in adolescents, including increased IgG and receptor inhibition titers against a wide array of variants, including Omicron, following a 2-dose series. Responses in adolescents were 2- to 4-fold higher than adults against all evaluated variants. As part of an ongoing study, a single booster dose of 5 µg SARS-CoV-2 rS with 50 µg Matrix-M™ adjuvant was administered to healthy adult participants approximately six months after their primary 2-dose vaccination series. Multiple assays were used to evaluate immune responses against SARS-CoV-2 twenty-eight days following the booster dose. Safety reporting of reactogenicity events showed an increasing trend across all 3 doses of NVX-CoV2373, reflecting the increased immunogenicity seen with a third dose. Following the booster, local and systemic reactions were generally short-lived with a median duration of approximately 2 days. The incidence of Grade 3 or higher events remained relatively low. Medically attended adverse events (MAAEs), potentially immune-mediated medical conditions (PIMMCs), and severe adverse events (SAEs) occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

Positive

Novavax, Inc. Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study

2021-12-21 22:01:00

Novavax, Inc. announced that the first booster doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant, have been administered in an extension of the company's PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. All PREVENT-19 trial participants are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least six months after receipt of active vaccine. The primary endpoint is the first occurrence of polymerase chain reaction (PCR)-confirmed mild, moderate or severe COVID-19 with onset at least seven days after the third (booster) vaccine dose. Two additional groups will be evaluated in this portion of the trial. Trial participants who initially received placebo and subsequently received a different COVID-19 vaccine are also eligible for a booster dose of NVX-CoV2373. Participants who were unblinded after initially receiving active vaccine and did not subsequently receive another vaccine will also be eligible to be boosted with NVX-CoV2373. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials. A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. PREVENT-19, a trial in the U.S. and Mexico, with 25,452 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response in both studies.

Positive

Novavax, Inc. Announces European Commission Grants Conditional Marketing Authorization for Nuvaxovid Covid-19 Vaccine

2021-12-20 16:21:00

Novavax, Inc. announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states. The EMA opinion and related EC decision is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 which included 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. Novavax and the EC announced an advance purchase agreement (APA) for up to 200 million doses of Novavax' COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January. Novavax is working with EMA and its partners to expedite local release testing. This authorization leverages Novavax' manufacturing partnership with Serum Institute of India (SII), which will supply initial doses for the E.U. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. Novavax and SII recently received emergency use authorization (EUA) in Indonesia and the Philippines, where it will be commercialized by SII under the trade name Covovax. The companies also received emergency use listing for Covovax from the World Health Organization. The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) by the end of the year.

Positive

Novavax, Inc. Files for Emergency Use of COVID-19 Vaccine in the United Arab Emirates

2021-12-13 11:30:00

Novavax, Inc. announced that it has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its COVID-19 vaccine in the United Arab Emirates (UAE). Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile. Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, the European Union,Singapore and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. The chemistry, manufacturing and controls (CMC) data package submitted to MoHaP and other global regulatory agencies leverages Novavax' manufacturing partnership with SII, the vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022

2021-12-10 06:32:00

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022. Venue: Chicago, Illinois, United States.

Negative

The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Novavax Investors

2021-12-02 16:35:00

The Law Offices of Frank R. Cruz announced that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Novavax, Inc. securities between March 2, 2021 and October 19, 2021, inclusive (the "Class Period"). Novavax investors have until January 11, 2022 to file a lead plaintiff motion. On May 10, 2021, The Washington Post reported that Novavax's Emergency Use Authorization ("EUA" "filing was delayed by manufacturing regulatory issues, until June at the earliest, according to four people who had recently been briefed on the [C]ompany's plans." Later that day, Novavax confirmed the claims, revealing that it was not likely to pursue an EUA for NVX-CoV2373 in the U.S. until its third quarter – July 2021 at the earliest. The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Novavax overstated its manufacturing capabilities and downplayed manufacturing issues that would impact its approval timeline for NVX-CoV2373; (ii) as a result, Novavax was unlikely to meet its anticipated EUA regulatory timelines for NVX-CoV2373; (iii) accordingly, the Company overstated the regulatory and commercial prospects for NVX-CoV2373; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

Positive

Novavax, Inc. Announces Submission to the Singapore Health Sciences Authority for Interim Authorization of Its Covid-19 Vaccine Under the Pandemic Special Access Route

2021-11-24 14:15:00

Novavax, Inc. announced its submission to the Singapore Health Sciences Authority (HSA) for interim authorization of its COVID-19 vaccine under the Pandemic Special Access Route (PSAR). Novavax has made the submission for the regulatory evaluation by HSA of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile. Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, the European Union and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. The chemistry, manufacturing and controls (CMC) data package submitted to HSA and other global regulatory agencies leverages Novavax' manufacturing partnership with SII, the world's large vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

Neutral

Novavax, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-02-2021 09:15 AM

2021-11-23 14:15:00

Novavax, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-02-2021 09:15 AM. Speakers: Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Positive

Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization

2021-11-17 16:25:00

Novavax, Inc. announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax' COVID-19 vaccine, which will be marketed in the European Union under the brand name Nuvaxovid™. The company announced earlier this month that it had completed the submission of all data and modules required by EMA for regulatory evaluation of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. EMA has indicated that its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks. The chemistry, manufacturing and controls (CMC) data package submitted to EMA and other global regulatory agencies leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII). It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. The Novavax/SII vaccine has recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. The brand name NuvaxovidTM has not been authorized by the U.S. FDA.

Positive

Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines

2021-11-17 14:29:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™. Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas. The Novavax/SII vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

Positive

Novavax Announces Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373

2021-11-15 13:45:00

Novavax, Inc. announced the submission of a Biologics License Application (BLA) for Novavax' COVID-19 vaccine to South Korea'sMinistry of Food and Drug Safety (MFDS). NVX-CoV2373, Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, is the first protein-based COVID-19 vaccine to be submitted for BLA in Korea. In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to the MFDS in April of this year. The completion of a BLA submission to the MFDS marks the final review stage for authorization of NVX-CoV2373 in Korea. Novavax and SK bioscience have an existing manufacturing and licensing collaboration that is intended to provide broad and equitable access to NVX-CoV2373 both in Korea and globally through the COVAX Facility. SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to South Korea earlier this year. Novavax recently announced authorization of its vaccine in Indonesia. The company also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand and Canada, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency. Novavax and the Serum Institute of India also announced filings in India and the Philippines in August. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

Negative

Pomerantz Law Firm Announces the Filing of Class Action Against Novavax, Inc. and Certain Officers

2021-11-13 04:38:00

Pomerantz LLP announced that a class action lawsuit has been filed against Novavax, Inc. and certain of its officers. The class action, filed in the United States District Court for the District of Maryland, Southern Division, and docketed under 21-cv-02910, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Novavax securities between March 2, 2021 and October 19, 2021, both dates inclusive, seeking to recover damages caused by Defendants violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. Throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Novavax overstated its manufacturing capabilities and downplayed manufacturing issues that would impact its approval timeline for NVX-CoV2373; (ii) as a result, Novavax was unlikely to meet its anticipated EUA regulatory timelines for NVX-CoV2373; (iii) accordingly, the Company overstated the regulatory and commercial prospects for NVX-CoV2373; and (iv) as a result, the company's public statements were materially false and misleading at all relevant times. On May 10, 2021, The Washington Post reported that Novavaxs EUA filing was delayed by manufacturing regulatory issues, until June at the earliest, according to four people who had recently been briefed on the company's plans. Later that day, during after-market hours, on a call that Novavax hosted with investors and analysts to discuss the company's first quarter 2021 financial and operational results, Novavax confirmed that it was unlikely to seek an EUA for NVX-CoV2373 in the U.S. until July 2021 at the earliest that is, the third quarter of 2021.

Neutral

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Center, San Diego, California, United States.

Neutral

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Center, San Diego, California, United States.

Negative

Novavax, Inc Announces Executive Appointments

2021-11-04 20:02:00

Novavax, Inc. Announced at the promotions of Jim Kelly as Executive Vice President, Chief Financial Officer and Treasurer Denny Kim, M.D. as Senior Vice President, Chief Safety Officer Marco Cacciuttolo, Ph.D. promoted to Senior Vice President, Process and Analytical Development Raburn Mallory, M.D. promoted to Senior Vice President, Head of Clinical Development.

Positive

Novavax Files Covid-19 Vaccine for Provisional Approval in New Zealand

2021-11-03 13:52:00

Novavax, Inc. announced the company has filed for provisional approval of the vaccine to the New Zealand Medicines and Medical Devices Safety Authority. Novavax has now completed the submission to Medsafe of all modules required for the regulatory evaluation of NVX-CoV2373, a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The chemistry, manufacturing and controls (CMC) module submitted to Medsafe, as well as other regulatory agencies worldwide, leverage Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. The submission includes clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also previously submitted to Medsafe, in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile. Novavax recently announced regulatory filings for its vaccine in the United Kingdom, Australia, and Canada, and the completion of all data and modules in the European Union. The company also expects to complete an additional supplemental filing for its vaccine for Emergency Use Listing with the World Health Organization shortly. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. This submission was facilitated by the company's local partner, Biocelect Pty. Ltd., as sponsor.

Positive

Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia

2021-11-01 10:47:00

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) announced that the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX™. Because the vaccine is stored at 2° to 8° Celsius, the use of existing vaccine supply channels with more traditional cold chain capabilities is possible, potentially increasing access in hard-to-reach areas and vaccination rates across the nation. Initial shipments into Indonesia are expected to begin imminently. Novavax and SII have already filed for authorization of Novavax' COVID-19 vaccine in India and the Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax recently also completed rolling submissions for authorization of the Novavax vaccine with regulatory agencies in the United Kingdom, European Union, Canada and Australia. Novavax expects to submit additional regulatory filings for its vaccine around the world as well as an additional supplemental filing for its vaccine for EUL with the WHO, shortly. Novavax expects to submit its complete package to the U.S. FDA by the end of the year. Badan POM has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above. COVOVAX is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response. It is also being evaluated in a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. NVX-CoV2373, Novavax' Covid-19 vaccine, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Positive

Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency

2021-11-01 10:20:00

Novavax, Inc. announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada. In addition, the company has completed the submission of all data and modules to the European Medicines Agency (EMA) to support the final regulatory review of its dossier. Novavax has now completed the submission of all modules required by Health Canada and EMA for the regulatory evaluation of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The final step to completing the application in the European Union will be an invitation from EMA to file for Conditional Marketing Authorization. The chemistry, manufacturing and controls (CMC) data packages submitted to Health Canada and EMA, as well as other global regulatory agencies, leverage Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's large supplier of COVID-19 vaccines. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain. The submissions also include clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also previously submitted to the regulatory agencies, in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile. Novavax recently announced regulatory filings for its vaccine in the United Kingdom and Australia and expects to complete additional regulatory filings shortly in multiple additional markets, along with an additional supplemental filing for its vaccine for Emergency Use Listing (EUL) with the World Health Organization. Novavax expects to submit the complete package to the U.S. FDA by the end of the year. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M™ adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, United States.

Positive

Novavax, Inc. Files for Provisional Approval of its COVID-19 Vaccine in Australia

2021-10-29 11:15:00

Novavax, Inc. announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine candidate. The company's application to the TGA marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia. Novavax has now completed the submission of all modules required by the TGA for the regulatory evaluation of its COVID-19 vaccine. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. was submitted to the TGA earlier this year in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile. Clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall, was also submitted to the TGA. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M™ adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Positive

Novavax, Inc. Files for Authorization of its COVID-19 Vaccine in the United Kingdom

2021-10-27 15:09:00

Novavax, Inc. announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate. The company’s application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom. Novavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was submitted to MHRA earlier this year in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile. The submission also includes data from PREVENT-19, a 30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was generally well-tolerated and elicited a robust antibody response. Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year. The company continues to work closely with governments, regulatory authorities and non-governmental organizations (NGOs) in its commitment to ensuring equitable global access to its COVID-19 vaccine. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19. Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M™ adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Novavax, Inc., Q3 2021 Earnings Call, Nov 04, 2021

2021-10-18 13:15:00

Novavax, Inc., Q3 2021 Earnings Call, Nov 04, 2021

Neutral

Novavax, Inc. to Report Q3, 2021 Results on Nov 04, 2021

2021-10-18 13:15:00

Novavax, Inc. announced that they will report Q3, 2021 results After-Market on Nov 04, 2021

Negative

Novavax, Inc. Announces Executive Appointments

2021-10-04 20:05:00

Novavax, Inc. announced the appointment of Denny Kim, M.D., MPH to the newly created role of Senior Vice President, Chief Safety Officer and Head of Global Vaccine Safety. Dr. Kim will report to Filip Dubovsky, M.D., MPH, FAAP, Executive Vice President and Chief Medical Officer. Novavax also announced the promotions of Raburn Mallory, M.D. to Senior Vice President, Head of Clinical Development, and Marco Cacciuttolo, Ph.D. to Senior Vice President, Process and Analytical Development. Dr. Kim brings nearly two decades of infectious disease, clinical trial and safety experience to Novavax. He joins the company from Johnson & Johnson (J&J), where he was part of the Office of the Chief Medical Officer with oversight for safety strategies and activities across all therapeutic areas, including direct management responsibilities for the safety of the J&J/Janssen COVID-19 vaccine. Dr. Raburn Mallory has been promoted to Senior Vice President and Head of Clinical Development. In his new role, Dr. Mallory will lead the clinical development organization, provide strategic direction for the life-cycle management of Novavax' vaccines and play a key role in regulatory filings. Dr. Marco Cacciuttolo has been promoted to Senior Vice President of Process and Analytical Development. In his new role, he will continue to ensure the technical quality and safety of Novavax' vaccine candidates.

Positive

Novavax, Inc. Announces Results from Novavax Nanoflu Influenza Vaccine Phase 3 Clinical Trial Published in the Lancet Infectious Diseases

2021-09-24 00:03:00

Novavax, Inc. announced publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M™ adjuvant, in The Lancet Infectious Diseases (Lancet ID). The trial evaluated the immunogenicity and safety of NanoFlu in older adults compared to a leading U.S.-licensed quadrivalent influenza vaccine. In the complete analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine. Novavax previously announced that NanoFlu achieved the trial's primary endpoints, demonstrating non-inferior immunogenicity to Fluzone® Quadrivalent against all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as compared to Fluzone Quadrivalent. Additionally, NanoFlu showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A/H3N2 and B/Victoria strains, with a 126–189% increase in various post-vaccination cell-mediated immunity markers as compared to Fluzone Quadrivalent.

Positive

Novavax, Inc. and Serum Institute of India Pvt. Ltd. Announce Submission to World Health Organization for Emergency Use Listing of Novavax' Covid-19 Vaccine

2021-09-23 13:25:00

Novavax, Inc. with its partner, Serum Institute of India Pvt. Ltd. announced a regulatory submission to the World Health Organization for emergency use listing of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The submission to WHO is based on the companies' previous regulatory submission to the Drugs Controller General of India. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Novavax, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-29-2021 08:40 AM

2021-09-23 13:15:00

Novavax, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-29-2021 08:40 AM. Venue: New York, United States. Speakers: Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Neutral

Novavax, Inc. - Special Call

2021-09-20 20:05:00

To discuss on Novavax' COVID-19 vaccine candidate, NVX-CoV2373 along with fostering global vaccine access

Neutral

Novavax, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-10-2021 02:00 PM

2021-09-09 13:54:00

Novavax, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-10-2021 02:00 PM. Venue: New Windsor, United States. Speakers: Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Neutral

Novavax, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-12-2021 through Sep-16-2021

2021-09-09 13:25:00

Novavax, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-12-2021 through Sep-16-2021. Venue: Lotte New York Palace Hotel, New York City, New York, United States. Presentation Date & Speakers: Sep-13-2021, Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer. Sep-15-2021, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Positive

Novavax, Inc. Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza

2021-09-08 12:23:00

Novavax, Inc. announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax' seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax' recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. The trial will evaluate the safety, tolerability and immune response to NanoFlu formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be dosed on Day 0 and again at Day 56. The trial will be conducted in Australia at up to 12 study sites, with results expected during the first half of 2022. In preclinical studies, the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role. In a Phase 3 clinical trial with nearly 30,000 adults in the United States and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe COVID-19 infection and 90.4% efficacy overall. In a pivotal Phase 3 trial conducted among adults aged 65 and older, NanoFlu achieved the primary endpoints, demonstrating non-inferior immunogenicity to a licensed comparator on all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous and multiple heterologous A/H3N2 strains, and potent induction of T cell responses. NVX-CoV2373 has also been evaluated in a co-administration study where it was administered simultaneously with an approved influenza vaccine. The study demonstrated that vaccine efficacy appeared to be preserved in those receiving both vaccines compared to those vaccinated with NVX-CoV2373 alone. About NVX-CoV2373: NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials. Recombinant spike protein used in this study was manufactured at Novavax' plant located in the Czech Republic. About Matrix-M™ Adjuvant: Novavax's patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Neutral

Novavax, Inc. Presents at Citi’s 16th Annual BioPharma Virtual Conference, Sep-09-2021 04:10 PM

2021-09-07 08:49:00

Novavax, Inc. Presents at Citi’s 16th Annual BioPharma Virtual Conference, Sep-09-2021 04:10 PM. Venue: New York, United States. Speakers: Gregory M. Glenn, President of Research & Development, John Joseph Trizzino, Executive VP and Chief Business & Commercial Officer.

Neutral

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021

2021-08-24 20:29:00

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021.

Negative

Novavax, Inc. Announces Executive Appointments

2021-08-17 15:26:00

Novavax, Inc. announced the appointment of Jim Kelly as Executive Vice President, and Treasurer, and Nasir Egal, Ph.D. as Senior Vice President, Quality Assurance. Mr. Kelly will report to Stanley C. Erck, President and Chief Executive Officer, and Dr. Egal will report to Rick Crowley, Executive Vice President and Chief Operations Officer. Mr. Kelly brings more than twenty-five years of industry experience in both commercial and clinical-stage companies to Novavax. He joins Novavax from Supernus Pharmaceuticals, where he served as CFO. Previously, he spent ten years at Vanda Pharmaceuticals, where he was CFO and Treasurer. Earlier, he spent over a decade in finance roles of increasing responsibility at MedImmune (now AstraZeneca) and Biogen. Dr. Egal brings a diverse range of global quality experience to Novavax. He most recently served as the Head of Global Quality External Affairs at Sanofi, where he spent nearly a decade in roles of increasing responsibility. Earlier in his career, he held global and regional quality and compliance roles at Novartis and Merck. He also spent time at the United States Food and Drug Administration as a research scientist.

Negative

Novavax, Inc. Appoints Jim Kelly as Chief Financial Officer

2021-08-16 12:50:00

Novavax, Inc. announced the appointment of Jim Kelly as Executive Vice President, Chief Financial Officer (CFO) and Treasurer. Mr. Kelly will report to Stanley C. Erck, President and Chief Executive Officer, and Dr. Egal will report to Rick Crowley, Executive Vice President and Chief Operations Officer. Mr. Kelly brings more than twenty-five years of industry experience in both commercial and clinical-stage companies to Novavax. He joins Novavax from Supernus Pharmaceuticals, where he served as CFO. Previously, he spent ten years at Vanda Pharmaceuticals, where he was CFO and Treasurer. Earlier, he spent over a decade in finance roles of increasing responsibility at MedImmune (now AstraZeneca) and Biogen.

Positive

Novavax, Inc. Announces Covid-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

2021-08-05 20:04:00

Novavax, Inc. announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers. Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant were more than 6-fold higher than the primary vaccination series. Complete data from the study will be submitted to a peer review publication and posted to a preprint server. The results come from an ongoing Phase 2 study in the U.S. and Australia in which select participants in the 5-microgram dose cohort received a 5-microgram booster dose 189 days after the initial two-dose regimen to examine the functional immune response. Twenty-eight days following boosting, anti-spike IgG increased approximately 4.6-fold compared to the peak response seen after the second dose (Day 217 GMEU = 200,408 (95% CI: 159,796; 251,342)). This boosted value represents a 3.7 to 4.4-fold increase in anti-spike IgG values that were associated with protection in Novavax' PREVENT-19 and U.K. Phase 3 clinical studies. Similarly, wild-type neutralization responses increased approximately 4.3-fold compared to the peak response seen after Dose 2 (IC50 neutralization titers = 6,231 (95% CI: 4,738; 8,195)). This boosted value represents a 4.6 to 5.5-fold increase over the neutralization response associated with protection in the PREVENT-19 and U.K. Phase 3 clinical trials. Older participants (aged 60-84) showed a 5.4-fold increase in antibody responses, while younger participants (aged 18-59) showed a 3.7-fold increase. Very high levels of functional antibodies to the Alpha (B.1.1.7), Beta (B.1.351) and Delta variants were induced by boosting with NVX-CoV2373, with a 6.6-fold higher Delta variant-specific response when compared to the Delta response observed with the primary vaccination series.

Positive

Novavax and Serum Institute of India Announces Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax' Recombinant Nanoparticle COVID-19 Vaccine

2021-08-05 20:03:00

Novavax, Inc. with its partner, Serum Institute of India Pvt. Ltd. announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The submissions were made to the Drugs Controller General of India and regulatory agencies in Indonesia and the Philippines. SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. A Good Manufacturing Practice joint site inspection of SII was successfully completed by DCGI in May 2021. A submission to the World Health Organization for emergency use listing based on the DCGI submission is expected to be filed in August. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. SII is manufacturing, and developing, and is responsible for commercializing the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.

Neutral

Novavax, Inc. has filed a Shelf Registration in the amount of $335.715 million.

2021-08-05 00:00:00

Novavax, Inc. has filed a Shelf Registration in the amount of $335.715 million. Security Name: Common Stock Securities Offered: 1,500,000 Transaction Features: ESOP Related Offering

Neutral

Novavax and European Commission Finalize Advance Purchase Agreement for Up to 200 Million Doses of Covid-19 Vaccine

2021-08-04 13:10:00

Novavax, Inc. announced that it has reached an agreement with the European Commission (EC) for the purchase of up to 200 million doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023. Novavax is working to complete its rolling submission for NVX-CoV2373 to the European Medicines Agency (EMA) in the third quarter of 2021, with delivery of initial doses expected to begin following approval. In a Phase 3 clinical trial with nearly 30,000 adults in the United States and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe disease and 90.4% overall efficacy. In a Phase 3 clinical trial conducted in the United Kingdom with approximately 15,000 adults, NVX-CoV2373 showed an overall efficacy of 89.7%, and more than 96% efficacy against the original strain of the virus. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7 (Alpha) variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

Neutral

Novavax, Inc. to Report Q2, 2021 Results on Aug 05, 2021

2021-07-06 12:30:00

Novavax, Inc. announced that they will report Q2, 2021 results After-Market on Aug 05, 2021

Neutral

Novavax, Inc., Q2 2021 Earnings Call, Aug 05, 2021

2021-07-06 12:30:00

Novavax, Inc., Q2 2021 Earnings Call, Aug 05, 2021

Positive

Novavax, Inc. Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine

2021-06-30 21:26:00

Novavax, Inc. announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the United Kingdom in the New England Journal of Medicine (NEJM). The final analysis confirmed an overall efficacy of 89.7% with over 60% (half) of the cases caused by the B.1.1.7 (Alpha) variant, and a 96.4% efficacy against non-B.1.1.7 (non-Alpha) variants which represents strains most similar to the original virus. The randomized, observer-blinded, placebo-controlled study, led by researchers at St George's, University of London and St George's Hospital, London, enrolled more than 15,000 adults at trial sites across the United Kingdom. The research demonstrated that a two-dose regimen of Novavax' COVID-19 vaccine candidate conferred 96.4% protection against non-B.1.1.7 (non-Alpha) variant strains and nearly 90% protection against all strains in circulation at that time. It also demonstrated that initial vaccine side effects were mostly mild and transient, and that no imbalance was seen in more serious adverse events compared with the placebo arm. The study assessed efficacy during a period when the B.1.1.7 (Alpha) variant strain of the virus was emerging and circulating widely in the United Kingdom and is the same variant that is currently widespread in the United States.NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-MTM to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7 (Alpha) variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

Fundamental Summary

Novavax released impressive Q1 results on 2022-05-10. Their growth and value factors performance indicate that company management is focused on the right targets and executing well. This relative strength should allow Novavax to continue to perform well even in a tough market. We therefore gave Novavax a total score of 74 out of 100 and a HOLD recommendation.

Novavax reported earnings results for the first quarter ended March 31, 2022. For the first quarter, the company reported revenue was USD 703.97 million compared to USD 447.23 million a year ago. Net income was USD 203.41 million compared to net loss of USD 222.72 million a year ago. Basic earnings per share from continuing operations was USD 2.66 compared to basic loss per share from continuing operations of USD 3.05 a year ago. Diluted earnings per share from continuing operations was USD 2.56 compared to diluted loss per share from continuing operations of USD 3.05 a year ago.

Business Description

Novavax, a biotechnology company, focuses on the discovery, development, and commercialization of vaccines to prevent serious infectious diseases and address health needs. The company's vaccine candidates include NVX-CoV2373, a coronavirus vaccine candidate that is in two Phase III trials, one Phase IIb trial, and one Phase I/II trial; NanoFlu, a nanoparticle seasonal quadrivalent influenza vaccine candidate that is in Phase 3 clinical trial; and ResVax, a respiratory syncytial virus (RSV) fusion (F) protein nanoparticle vaccine candidate. It is also developing RSV F vaccine that is in Phase II clinical trial for older adults (60 years and older), as well as that is in Phase I clinical trial for pediatrics. It has a collaboration agreement with Takeda Pharmaceutical Company Limited for the development, manufacturing, and commercialization of NVX-CoV2373, a COVID-19 vaccine candidate. Novavax was incorporated in 1987 and is headquartered in Gaithersburg, Maryland.

Sector Overview

Novavax 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. Novavax's industry and sector affiliation are expected to negatively affect their likelihood to overperform the market in the upcoming period, as other sectors appear more likely to benefit from the macroeconomic environment we see now.

Fundamental Highlights


Parameter Value Change Score
Assets 2,834.9 10.0% 67
Liabilities 2,769.6 -5.4% 61
Price to Book 43.4 240.6% 99
Cash & Equivalents 1,571.0 3.7% 77
Equity 65.3 118.6% 52
EBITDA -679.4 35.4% 89
Total Revenues 1,403.0 22.4% 41
Parameter Value Change Score
Return on Equity -238.6 81.1% 54
Net Cashflow -445.0 -150.6% 62
Capital Expenditure -60.5 -5.3% 63
Asset Turnover 0.5 -6.5% 54
Free Cashflow -6.5 -282.2% 38

* All values are TTM

The below chart reflects Novavax'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 Novavax's peer average final assessment score stands on 62.0, Novavax's score is 74.

  •  NVAX
  •  Peers average
Name Market Cap Balance Sheet Income Statement Cash Flow Rating Final Assessment mc_sort Hidden
Amgen Inc. 130.1B 69 78 81
Hold
77
77 0 1
Gilead Sciences, Inc. 78.0B 57 73 62
Underperform
60
60 1 1
Vertex Pharmaceuticals Incorporated 70.6B 78 75 71
Buy
79
79 2 1
Regeneron Pharmaceuticals, Inc. 64.0B 67 74 73
Hold
72
72 3 1
BioNTech SE 34.0B 75 79 72
Buy
79
79 4 1
Seagen Inc. 32.9B 61 62 58
Underperform
57
57 5 1
Biogen Inc. 29.7B 76 70 66
Hold
74
74 6 1
Alnylam Pharmaceuticals, Inc. 17.2B 54 80 85
Hold
69
69 7 1
Incyte Corporation 16.8B 83 73 84
Buy
86
86 8 1
BioMarin Pharmaceutical Inc. 15.4B 70 82 63
Hold
74
74 9 1
United Therapeutics Corporation 10.6B 76 82 93
Strong Buy
88
88 10 1
Neurocrine Biosciences, Inc. 9.3B 68 55 63
Underperform
60
60 11 1
Exelixis, Inc. 6.7B 70 81 87
Buy
81
81 12 1
Sarepta Therapeutics, Inc. 6.5B 58 78 93
Hold
73
73 13 1
Halozyme Therapeutics, Inc. 6.3B 74 82 75
Buy
81
81 14 1
Ionis Pharmaceuticals, Inc. 5.4B 62 86 89
Buy
79
79 15 1
Ascendis Pharma A/S 5.2B 68 54 62
Underperform
60
60 16 1
Alkermes plc 5.0B 62 62 92
Hold
69
69 17 1
Cytokinetics, Incorporated 4.1B 64 66 69
Hold
65
65 18 1
Mirati Therapeutics, Inc. 3.8B 50 64 65
Underperform
52
52 19 1
Natera, Inc. 3.6B 54 52 58
Underperform
47
47 20 1
Arrowhead Pharmaceuticals, Inc. 3.4B 71 76 70
Hold
74
74 21 1
PTC Therapeutics, Inc. 2.8B 51 73 72
Underperform
59
59 22 1
Insmed Incorporated 2.4B 55 57 82
Underperform
58
58 23 1
ACADIA Pharmaceuticals Inc. 2.3B 63 58 72
Hold
61
61 24 1
BioCryst Pharmaceuticals, Inc. 1.9B 55 66 67
Underperform
57
57 25 1
ChemoCentryx, Inc. 1.8B 61 73 87
Hold
71
71 26 1
Ironwood Pharmaceuticals, Inc. 1.8B 68 79 78
Hold
76
76 27 1
Myriad Genetics, Inc. 1.5B 52 96 59
Hold
66
66 28 1
Agios Pharmaceuticals, Inc. 1.2B 50 75 75
Hold
60
60 29 1
IVERIC bio, Inc. 1.1B 50 70 64
Underperform
54
54 30 1
FibroGen, Inc. 1.0B 73 67 84
Hold
76
76 31 1
Syndax Pharmaceuticals, Inc. 1.0B 58 62 57
Underperform
54
54 32 1
ImmunoGen, Inc. 946.1M 56 64 87
Hold
64
64 33 1
Enanta Pharmaceuticals, Inc. 922.8M 60 75 66
Hold
65
65 34 1
Deciphera Pharmaceuticals, Inc. 914.0M 61 77 94
Hold
75
75 35 1
Anavex Life Sciences Corp. 767.1M 61 75 72
Hold
67
67 36 1
Sangamo Therapeutics, Inc. 600.0M 48 76 91
Hold
65
65 37 1
AnaptysBio, Inc. 586.3M 52 68 80
Hold
60
60 38 1
Geron Corporation 566.2M 60 78 77
Hold
70
70 39 1
Mersana Therapeutics, Inc. 449.1M 58 47 65
Underperform
50
50 40 1
Inovio Pharmaceuticals, Inc. 416.9M 46 72 71
Underperform
54
54 41 1
Arbutus Biopharma Corporation 388.2M 60 67 95
Hold
71
71 42 1
Intercept Pharmaceuticals, Inc. 386.3M 57 86 96
Hold
78
78 43 1
Anika Therapeutics, Inc. 322.7M 64 77 63
Hold
73
73 44 1
Lexicon Pharmaceuticals, Inc. 321.6M 51 69 77
Hold
61
61 45 1
Precigen, Inc. 299.1M 73 79 74
Buy
79
79 46 1
bluebird bio, Inc. 288.7M 50 96 83
Hold
78
78 47 1
Rigel Pharmaceuticals, Inc. 187.5M 62 64 41
Underperform
52
52 48 1
MacroGenics, Inc. 184.6M 47 71 65
Underperform
53
53 49 1
Exact Sciences Corporation 7.2B 47 62 56
Underperform
46
46 50 1
Amicus Therapeutics, Inc. 3.0B 56 58 85
Hold
61
61 51 1
CureVac N.V. 2.6B 57 74 90
Hold
70
70 52 1
Fate Therapeutics, Inc. 2.4B 53 46 61
Underperform
45
45 53 1
Abgenix Inc. 2.1B 67 47 58
Underperform
45
45 54 1
Xenon Pharmaceuticals Inc. 1.9B 61 56 89
Hold
64
64 55 1
Iovance Biotherapeutics, Inc. 1.7B 63 71 77
Hold
68
68 56 1
Xencor, Inc. 1.6B 67 79 98
Buy
82
82 57 1
Emergent BioSolutions Inc. 1.6B 61 66 75
Hold
65
65 58 1
Dynavax Technologies Corporation 1.5B 63 67 68
Hold
64
64 59 1
Ligand Pharmaceuticals Incorporated 1.5B 56 69 84
Hold
65
65 60 1
Aurinia Pharmaceuticals Inc. 1.4B 52 70 84
Hold
62
62 61 1
Veracyte, Inc. 1.4B 57 55 82
Underperform
59
59 62 1
Sierra Oncology, Inc. 1.3B 80 61 52
Hold
68
68 63 1
Celldex Therapeutics, Inc. 1.3B 57 70 69
Hold
61
61 64 1
CareDx, Inc 1.2B 52 50 86
Underperform
54
54 65 1
Vericel Corporation 1.1B 57 56 65
Underperform
53
53 66 1
Avid Bioservices, Inc. 959.5M 67 75 66
Hold
69
69 67 1
MannKind Corporation 957.2M 57 61 66
Underperform
56
56 68 1
Merus N.V. 941.6M 70 54 71
Hold
64
64 69 1
Sorrento Therapeutics, Inc. 747.5M 74 55 52
Hold
61
61 70 1
Amarin Corporation plc 734.5M 55 63 55
Underperform
52
52 71 1
Catalyst Pharmaceuticals, Inc. 707.1M 75 77 87
Buy
84
84 72 1
Northwest Biotherapeutics, Inc. 682.9M 65 79 85
Hold
77
77 73 1
Organogenesis Holdings Inc. 612.1M 60 69 75
Hold
64
64 74 1
CTI BioPharma Corp. 603.6M 54 59 56
Underperform
50
50 75 1
Vanda Pharmaceuticals Inc. 598.8M 64 62 69
Hold
62
62 76 1
Eagle Pharmaceuticals, Inc. 546.4M 75 78 73
Buy
79
79 77 1
Immatics N.V. 538.7M 76 77 86
Buy
84
84 78 1
Agenus Inc. 520.5M 54 74 58
Underperform
57
57 79 1
Radius Health, Inc. 499.8M 54 82 57
Hold
61
61 80 1
Vaxart, Inc. 440.0M 53 68 65
Underperform
56
56 81 1
Affimed N.V. 415.0M 54 66 74
Underperform
59
59 82 1
ADMA Biologics, Inc. 396.6M 68 57 71
Hold
64
64 83 1
MiMedx Group, Inc. 391.5M 45 59 60
Underperform
45
45 84 1
Albireo Pharma, Inc. 362.9M 54 65 63
Underperform
55
55 85 1
AVEO Pharmaceuticals, Inc. 337.5M 66 74 95
Hold
78
78 86 1
Zymeworks Inc. 324.7M 62 56 57
Underperform
54
54 87 1
Heron Therapeutics, Inc. 314.6M 58 62 71
Underperform
59
59 88 1
Silence Therapeutics plc 313.4M 66 72 69
Hold
70
70 89 1
AC Immune SA 299.8M 68 70 68
Hold
68
68 90 1
Viridian Therapeutics, Inc. 293.2M 65 53 65
Underperform
56
56 91 1
Sutro Biopharma, Inc. 245.5M 61 56 74
Underperform
59
59 92 1
Chimerix, Inc. 178.4M 49 65 83
Underperform
58
58 93 1
DermTech, Inc. 165.3M 56 52 58
Underperform
47
47 94 1
Gelesis Holdings, Inc. 111.5M 78 39 80
Hold
66
66 95 1
Brooklyn ImmunoTherapeutics, Inc. 31.8M 49 61 58
Underperform
56
56 96 1
INSYS Therapeutics, Inc. 3.2M 43 70 73
Underperform
55
55 97 1

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. Novavax's stock is now priced above its 5-day and 50-day, but below its 200-day moving average, while its MACD (moving average convergence divergence) indicates that the stock's price movement momentum is weakening. Historically, this is a positive setup in both the short and medium-term. The company is trading near it's 12-month low, which signals it struggle to keep above it support price. Meanwhile, looking at the Stochastic Oscillator and RSI (relative strength index), Novavax's stock doesn't strongly signal being overbought or oversold. Overall, these technical indicators signal negative momentum. Therefore, this stock received a cumulative TA (technical analysis) score of 47.

Bearish 47
Close Price 51.06
52W Low 36.28
52W High 270.58
5D MA 50.77
50D MA 49.62
200D MA 115.2
MACD -0.47
RSI 58.59
STOCH 84.26

Balance Sheet Analysis

Two metrics jump up as the most significant positive drivers of the balance sheet strength in Novavax's recent report: Book Value Factors and Cash & Equivalents. Novavax publishes solid book value factor metrics in this report. Price to book ratio (P/B) now sits at 43.4 and represents a 240.6% change from the previous report. The company's book value factor metrics are even more remarkable when compared to their peers. Therefore, its book value factors earned a score of 99. Also, Novavax did a great job related to cash and cash equivalents this period, which stood at 1571.0, representing a 3.7% change from the previous filing. This performance is significantly more impressive than its peers and competitors. It suggests that their stock price has room to grow to reflect its actual intrinsic value. Therefore, its cash and cash equivalents movement earned a score of 77. On the other hand, Equity, jumped out as looking rather underwhelming. Novavax published concerning equity metrics for this filing. In the current report, equity stood at 65.3, which represents a 118.6% change from the last report. This parameter often affects companies in the same industry and market capitalization by up to 7.3%. Their equity metrics appear unremarkable relative to their peers. Consequently, their equity movement received a grade of 52. Their balance sheet, therefore, earned a score of 77.

Parameter Value Change Score
Assets 2,834.9 10.0% 67
Liabilities 2,769.6 -5.4% 61
Price to Book 43.4 240.6% 99
Cash & Equivalents 1,571.0 3.7% 77
Equity 65.3 118.6% 52
* All values are TTM

The below chart describes Novavax's performance as reflected on its balance sheet with respect to its peers. While Novavax received a balance sheet score of 77, the average of its peers stands on 62.0.

  •  NVAX
  •  Peers average
Name Market Cap Liabilities Movement Asset Change Equity/Intangibles Adjustments Cash & Equivalents Book Value Momentum Balance Sheet mc_sort Hidden
Amgen Inc. 130.1B 72 68 86 53 62 69 0 1
Gilead Sciences, Inc. 78.0B 48 63 61 52 62 57 1 1
Vertex Pharmaceuticals Incorporated 70.6B 69 69 58 84 92 78 2 1
Regeneron Pharmaceuticals, Inc. 64.0B 48 65 52 86 81 67 3 1
BioNTech SE 34.0B 75 69 64 97 73 75 4 1
Seagen Inc. 32.9B 59 68 55 43 66 61 5 1
Biogen Inc. 29.7B 57 72 92 50 76 76 6 1
Alnylam Pharmaceuticals, Inc. 17.2B 50 66 46 44 61 54 7 1
Incyte Corporation 16.8B 71 72 95 82 79 83 8 1
BioMarin Pharmaceutical Inc. 15.4B 55 75 54 77 74 70 9 1
United Therapeutics Corporation 10.6B 61 74 58 60 88 76 10 1
Neurocrine Biosciences, Inc. 9.3B 67 69 55 51 78 68 11 1
Exelixis, Inc. 6.7B 53 66 57 84 81 70 12 1
Sarepta Therapeutics, Inc. 6.5B 68 69 49 41 58 58 13 1
Halozyme Therapeutics, Inc. 6.3B 59 68 65 72 85 74 14 1
Ionis Pharmaceuticals, Inc. 5.4B 59 68 58 43 67 62 15 1
Ascendis Pharma A/S 5.2B 51 70 85 94 54 68 16 1
Alkermes plc 5.0B 63 66 46 54 71 62 17 1
Cytokinetics, Incorporated 4.1B 49 79 42 76 62 64 18 1
Mirati Therapeutics, Inc. 3.8B 53 66 57 48 42 50 19 1
Natera, Inc. 3.6B 73 65 43 95 42 54 20 1
Arrowhead Pharmaceuticals, Inc. 3.4B 72 71 63 65 73 71 21 1
PTC Therapeutics, Inc. 2.8B 57 61 80 49 37 51 22 1
Insmed Incorporated 2.4B 49 65 45 46 63 55 23 1
ACADIA Pharmaceuticals Inc. 2.3B 83 65 55 91 55 63 24 1
BioCryst Pharmaceuticals, Inc. 1.9B 46 67 46 50 62 55 25 1
ChemoCentryx, Inc. 1.8B 72 77 47 53 52 61 26 1
Ironwood Pharmaceuticals, Inc. 1.8B 49 68 87 67 63 68 27 1
Myriad Genetics, Inc. 1.5B 51 62 51 43 57 52 28 1
Agios Pharmaceuticals, Inc. 1.2B 50 66 52 38 48 50 29 1
IVERIC bio, Inc. 1.1B 50 67 46 48 48 50 30 1
FibroGen, Inc. 1.0B 79 87 49 82 56 73 31 1
Syndax Pharmaceuticals, Inc. 1.0B 85 68 41 55 55 58 32 1
ImmunoGen, Inc. 946.1M 52 67 64 61 48 56 33 1
Enanta Pharmaceuticals, Inc. 922.8M 51 86 45 38 49 60 34 1
Deciphera Pharmaceuticals, Inc. 914.0M 56 71 38 82 63 61 35 1
Anavex Life Sciences Corp. 767.1M 50 67 50 75 66 61 36 1
Sangamo Therapeutics, Inc. 600.0M 59 64 47 45 46 48 37 1
AnaptysBio, Inc. 586.3M 85 63 41 37 51 52 38 1
Geron Corporation 566.2M 69 72 37 59 62 60 39 1
Mersana Therapeutics, Inc. 449.1M 75 68 39 82 52 58 40 1
Inovio Pharmaceuticals, Inc. 416.9M 56 66 38 54 40 46 41 1
Arbutus Biopharma Corporation 388.2M 86 65 61 48 55 60 42 1
Intercept Pharmaceuticals, Inc. 386.3M 46 68 57 41 61 57 43 1
Anika Therapeutics, Inc. 322.7M 76 68 63 64 65 64 44 1
Lexicon Pharmaceuticals, Inc. 321.6M 48 68 51 43 51 51 45 1
Precigen, Inc. 299.1M 81 85 61 72 48 73 46 1
bluebird bio, Inc. 288.7M 48 67 42 38 57 50 47 1
Rigel Pharmaceuticals, Inc. 187.5M 53 67 51 90 63 62 48 1
MacroGenics, Inc. 184.6M 53 64 61 37 39 47 49 1
Exact Sciences Corporation 7.2B 57 58 45 42 52 47 50 1
Amicus Therapeutics, Inc. 3.0B 52 64 58 66 56 56 51 1
CureVac N.V. 2.6B 49 64 75 52 52 57 52 1
Fate Therapeutics, Inc. 2.4B 63 70 54 39 45 53 53 1
Abgenix Inc. 2.1B 81 57 86 92 45 67 54 1
Xenon Pharmaceuticals Inc. 1.9B 48 69 53 45 70 61 55 1
Iovance Biotherapeutics, Inc. 1.7B 52 74 72 87 45 63 56 1
Xencor, Inc. 1.6B 53 78 60 40 67 67 57 1
Emergent BioSolutions Inc. 1.6B 48 62 87 48 61 61 58 1
Dynavax Technologies Corporation 1.5B 52 69 54 38 76 63 59 1
Ligand Pharmaceuticals Incorporated 1.5B 75 63 61 49 52 56 60 1
Aurinia Pharmaceuticals Inc. 1.4B 51 67 59 41 47 52 61 1
Veracyte, Inc. 1.4B 64 68 54 66 51 57 62 1
Sierra Oncology, Inc. 1.3B 62 71 52 97 97 80 63 1
Celldex Therapeutics, Inc. 1.3B 48 69 61 44 57 57 64 1
CareDx, Inc 1.2B 54 67 52 39 51 52 65 1
Vericel Corporation 1.1B 51 65 56 53 61 57 66 1
Avid Bioservices, Inc. 959.5M 75 61 61 58 72 67 67 1
MannKind Corporation 957.2M 79 59 50 40 64 57 68 1
Merus N.V. 941.6M 59 68 50 83 81 70 69 1
Sorrento Therapeutics, Inc. 747.5M 89 71 50 97 73 74 70 1
Amarin Corporation plc 734.5M 51 65 58 72 51 55 71 1
Catalyst Pharmaceuticals, Inc. 707.1M 52 69 70 77 86 75 72 1
Northwest Biotherapeutics, Inc. 682.9M 65 63 48 38 86 65 73 1
Organogenesis Holdings Inc. 612.1M 59 66 56 66 60 60 74 1
CTI BioPharma Corp. 603.6M 84 70 37 92 37 54 75 1
Vanda Pharmaceuticals Inc. 598.8M 82 70 47 89 56 64 76 1
Eagle Pharmaceuticals, Inc. 546.4M 83 70 73 46 79 75 77 1
Immatics N.V. 538.7M 56 70 84 95 73 76 78 1
Agenus Inc. 520.5M 73 62 37 55 60 54 79 1
Radius Health, Inc. 499.8M 50 64 50 44 59 54 80 1
Vaxart, Inc. 440.0M 69 67 47 56 47 53 81 1
Affimed N.V. 415.0M 56 66 63 56 47 54 82 1
ADMA Biologics, Inc. 396.6M 74 68 49 77 72 68 83 1
MiMedx Group, Inc. 391.5M 53 66 42 57 37 45 84 1
Albireo Pharma, Inc. 362.9M 48 65 42 58 62 54 85 1
AVEO Pharmaceuticals, Inc. 337.5M 76 68 61 78 60 66 86 1
Zymeworks Inc. 324.7M 77 69 70 90 43 62 87 1
Heron Therapeutics, Inc. 314.6M 84 65 48 43 58 58 88 1
Silence Therapeutics plc 313.4M 58 71 69 63 59 66 89 1
AC Immune SA 299.8M 84 64 47 53 75 68 90 1
Viridian Therapeutics, Inc. 293.2M 56 72 44 37 76 65 91 1
Sutro Biopharma, Inc. 245.5M 82 69 56 66 49 61 92 1
Chimerix, Inc. 178.4M 48 63 46 95 40 49 93 1
DermTech, Inc. 165.3M 76 72 51 52 43 56 94 1
Gelesis Holdings, Inc. 111.5M 47 76 48 76 98 78 95 1
Brooklyn ImmunoTherapeutics, Inc. 31.8M 37 71 45 39 55 49 96 1
INSYS Therapeutics, Inc. 3.2M 48 70 44 90 37 43 97 1

Income Statement Analysis

EBITDA and Return Factors stand out as the most significant drivers of Novavax's income statement's strength. Novavax's management did a remarkable job this period managing its EBITDA. In terms of the raw numbers, EBITDA was reported as -679.4, which represents a 35.4% change from the last period. Companies in the same industry and market capitalization are typically affected by this parameter by up to 24.4%. Their EBITDA metrics are even more impressive relative to their peers and competitors, and its likely the stock price has room to grow to reflect its intrinsic value accurately. Therefore, its EBITDA component earned a score of 89. Also, Novavax's reported return on equity (ROE) ratio was -238.6, representing a change of 81.1%. These numbers show that management has successfully encouraged growth while managing ROE and ROA metrics, especially relative to their peers. Consequently, their return factors received a grade of 54. On the other hand, Revenue Efficiency, jumped out as looking rather underwhelming. Novavax management did an underwhelming job managing revenue efficiency this past period. Novavax's revenue efficiency is 1403.0 according to the metrics in the current filing, which represents a 22.4% change from the previous report. This metric might have a 13.1 percent impact on companies in the same industry and with the same market capitalization. Their revenue efficiency does not make a compelling case for upward pressure on the company's stock price. Consequently, their revenue efficiency received a grade of 41. Therefore, their income statement earned a grade of 75.

Parameter Value Change Score
EBITDA -679.4 35.4% 89
Total Revenues 1,403.0 22.4% 41
Return on Equity -238.6 81.1% 54
* All values are TTM

The below chart describes Novavax's performance as reflected on its income statement with respect to its peers. While Novavax received a income statement score of 75 , the average of its peers stands on 65.0.

  •  NVAX
  •  Peers average
Name Market Cap Revenue Momentum Earning Movement Return Factors Momentum Income Statement mc_sort Hidden
Amgen Inc. 130.1B 74 75 64 78 0 1
Gilead Sciences, Inc. 78.0B 78 71 52 73 1 1
Vertex Pharmaceuticals Incorporated 70.6B 57 80 62 75 2 1
Regeneron Pharmaceuticals, Inc. 64.0B 67 74 66 74 3 1
BioNTech SE 34.0B 41 89 75 79 4 1
Seagen Inc. 32.9B 54 65 70 62 5 1
Biogen Inc. 29.7B 90 57 73 70 6 1
Alnylam Pharmaceuticals, Inc. 17.2B 60 86 56 80 7 1
Incyte Corporation 16.8B 59 77 60 73 8 1
BioMarin Pharmaceutical Inc. 15.4B 72 81 65 82 9 1
United Therapeutics Corporation 10.6B 57 91 54 82 10 1
Neurocrine Biosciences, Inc. 9.3B 53 54 77 55 11 1
Exelixis, Inc. 6.7B 54 91 54 81 12 1
Sarepta Therapeutics, Inc. 6.5B 49 89 55 78 13 1
Halozyme Therapeutics, Inc. 6.3B 53 84 85 82 14 1
Ionis Pharmaceuticals, Inc. 5.4B 62 94 53 86 15 1
Ascendis Pharma A/S 5.2B 38 68 46 54 16 1
Alkermes plc 5.0B 69 55 81 62 17 1
Cytokinetics, Incorporated 4.1B 95 50 73 66 18 1
Mirati Therapeutics, Inc. 3.8B 76 55 78 64 19 1
Natera, Inc. 3.6B 52 51 78 52 20 1
Arrowhead Pharmaceuticals, Inc. 3.4B 38 92 53 76 21 1
PTC Therapeutics, Inc. 2.8B 54 78 66 73 22 1
Insmed Incorporated 2.4B 51 58 73 57 23 1
ACADIA Pharmaceuticals Inc. 2.3B 72 49 80 58 24 1
BioCryst Pharmaceuticals, Inc. 1.9B 41 74 72 66 25 1
ChemoCentryx, Inc. 1.8B 97 57 71 73 26 1
Ironwood Pharmaceuticals, Inc. 1.8B 70 79 61 79 27 1
Myriad Genetics, Inc. 1.5B 89 93 57 96 28 1
Agios Pharmaceuticals, Inc. 1.2B 99 64 54 75 29 1
IVERIC bio, Inc. 1.1B 84 58 79 70 30 1
FibroGen, Inc. 1.0B 48 74 63 67 31 1
Syndax Pharmaceuticals, Inc. 1.0B 87 47 81 62 32 1
ImmunoGen, Inc. 946.1M 40 73 71 64 33 1
Enanta Pharmaceuticals, Inc. 922.8M 90 63 72 75 34 1
Deciphera Pharmaceuticals, Inc. 914.0M 60 79 70 77 35 1
Anavex Life Sciences Corp. 767.1M 84 69 60 75 36 1
Sangamo Therapeutics, Inc. 600.0M 72 72 73 76 37 1
AnaptysBio, Inc. 586.3M 97 50 77 68 38 1
Geron Corporation 566.2M 89 67 73 78 39 1
Mersana Therapeutics, Inc. 449.1M 37 54 72 47 40 1
Inovio Pharmaceuticals, Inc. 416.9M 96 57 68 72 41 1
Arbutus Biopharma Corporation 388.2M 37 82 53 67 42 1
Intercept Pharmaceuticals, Inc. 386.3M 71 93 40 86 43 1
Anika Therapeutics, Inc. 322.7M 63 80 62 77 44 1
Lexicon Pharmaceuticals, Inc. 321.6M 98 48 82 69 45 1
Precigen, Inc. 299.1M 57 87 59 79 46 1
bluebird bio, Inc. 288.7M 99 91 61 96 47 1
Rigel Pharmaceuticals, Inc. 187.5M 99 44 82 64 48 1
MacroGenics, Inc. 184.6M 95 56 74 71 49 1
Exact Sciences Corporation 7.2B 57 67 54 62 50 1
Amicus Therapeutics, Inc. 3.0B 61 55 77 58 51 1
CureVac N.V. 2.6B 45 83 71 74 52 1
Fate Therapeutics, Inc. 2.4B 45 52 61 46 53 1
Abgenix Inc. 2.1B 47 47 47 47 54 1
Xenon Pharmaceuticals Inc. 1.9B 41 65 59 56 55 1
Iovance Biotherapeutics, Inc. 1.7B 84 60 75 71 56 1
Xencor, Inc. 1.6B 42 94 52 79 57 1
Emergent BioSolutions Inc. 1.6B 91 51 77 66 58 1
Dynavax Technologies Corporation 1.5B 51 69 77 67 59 1
Ligand Pharmaceuticals Incorporated 1.5B 92 53 78 69 60 1
Aurinia Pharmaceuticals Inc. 1.4B 38 81 68 70 61 1
Veracyte, Inc. 1.4B 45 63 57 55 62 1
Sierra Oncology, Inc. 1.3B 84 54 54 61 63 1
Celldex Therapeutics, Inc. 1.3B 96 53 78 70 64 1
CareDx, Inc 1.2B 61 44 82 50 65 1
Vericel Corporation 1.1B 76 44 82 56 66 1
Avid Bioservices, Inc. 959.5M 49 82 69 75 67 1
MannKind Corporation 957.2M 95 48 56 61 68 1
Merus N.V. 941.6M 48 60 59 54 69 1
Sorrento Therapeutics, Inc. 747.5M 50 60 60 55 70 1
Amarin Corporation plc 734.5M 95 44 82 63 71 1
Catalyst Pharmaceuticals, Inc. 707.1M 48 88 58 77 72 1
Northwest Biotherapeutics, Inc. 682.9M 43 90 65 79 73 1
Organogenesis Holdings Inc. 612.1M 89 55 79 69 74 1
CTI BioPharma Corp. 603.6M 84 50 62 59 75 1
Vanda Pharmaceuticals Inc. 598.8M 89 46 81 62 76 1
Eagle Pharmaceuticals, Inc. 546.4M 39 94 53 78 77 1
Immatics N.V. 538.7M 37 93 53 77 78 1
Agenus Inc. 520.5M 57 83 45 74 79 1
Radius Health, Inc. 499.8M 94 71 68 82 80 1
Vaxart, Inc. 440.0M 99 51 72 68 81 1
Affimed N.V. 415.0M 95 49 75 66 82 1
ADMA Biologics, Inc. 396.6M 43 65 62 57 83 1
MiMedx Group, Inc. 391.5M 87 43 83 59 84 1
Albireo Pharma, Inc. 362.9M 46 69 77 65 85 1
AVEO Pharmaceuticals, Inc. 337.5M 38 89 54 74 86 1
Zymeworks Inc. 324.7M 58 53 77 56 87 1
Heron Therapeutics, Inc. 314.6M 61 60 75 62 88 1
Silence Therapeutics plc 313.4M 83 64 69 72 89 1
AC Immune SA 299.8M 83 61 65 70 90 1
Viridian Therapeutics, Inc. 293.2M 55 50 63 53 91 1
Sutro Biopharma, Inc. 245.5M 60 47 80 56 92 1
Chimerix, Inc. 178.4M 99 50 62 65 93 1
DermTech, Inc. 165.3M 49 48 78 52 94 1
Gelesis Holdings, Inc. 111.5M 41 46 56 39 95 1
Brooklyn ImmunoTherapeutics, Inc. 31.8M 83 49 92 61 96 1
INSYS Therapeutics, Inc. 3.2M 97 48 63 70 97 1

Cash Flow Analysis

Overall, Novavax's critical cash flow metrics appear to signal strong support and a high likelihood of positive growth going forward. Novavax's management was effective in improving its CapEx, which now sits at -60.5 and represents -5.3% change from the previous report. This remarkable CapEx growth is expected to reinforce upward momentum for its's stock price going forward. Therefore, its CapEx movement component earned a score of 63. Also, Novavax's management was effective in improving their net cash flow, which now sits at -445.0 and represents a -150.6% change from the previous report. The company is headed in the right direction regarding business priorities, exhibiting prudent net cash flow management and growth. Hence, its net cash flow earned a score of 62. However, one discouraging result, Free Cash flow, stood out. Novavax did a poor job related to generating and maintaining strong free cash flow this period, which stood at -6.5, representing a -282.2% change from the previous filing. Companies in the same sector and market capitalization will usually be affected by up to 2.6 percent by this parameter. These free cash flow numbers show that management has not been executing well in generating critical cash flow while also encouraging growth. Consequently, their free cash flow movement received a grade of 38. The company's cash flow received an overall score of 60.

Parameter Value Change Score
Net Cashflow -445.0 -150.6% 62
Capital Expenditure -60.5 -5.3% 63
Asset Turnover 0.5 -6.5% 54
Free Cashflow -6.5 -282.2% 38
* All values are TTM

The below chart describes Novavax's performance as reflected on its cash flow with respect to its peers. While Novavax received a cash flow score of 60, the average of its peers stands on 67.0.

  •  NVAX
  •  Peers average
Name Market Cap Cashflow Momentum Free Cashflow Growth Capital Expenditure Growth Assets Factors Momentum Cash Flow mc_sort Hidden
Amgen Inc. 130.1B 80 74 67 74 81 0 1
Gilead Sciences, Inc. 78.0B 57 61 53 85 62 1 1
Vertex Pharmaceuticals Incorporated 70.6B 64 75 80 71 71 2 1
Regeneron Pharmaceuticals, Inc. 64.0B 69 86 64 66 73 3 1
BioNTech SE 34.0B 73 97 50 52 72 4 1
Seagen Inc. 32.9B 53 53 50 87 58 5 1
Biogen Inc. 29.7B 58 54 90 73 66 6 1
Alnylam Pharmaceuticals, Inc. 17.2B 82 80 70 89 85 7 1
Incyte Corporation 16.8B 78 79 92 74 84 8 1
BioMarin Pharmaceutical Inc. 15.4B 59 48 66 77 63 9 1
United Therapeutics Corporation 10.6B 93 92 68 80 93 10 1
Neurocrine Biosciences, Inc. 9.3B 63 43 54 74 63 11 1
Exelixis, Inc. 6.7B 79 90 89 83 87 12 1
Sarepta Therapeutics, Inc. 6.5B 85 89 95 87 93 13 1
Halozyme Therapeutics, Inc. 6.3B 83 66 52 49 75 14 1
Ionis Pharmaceuticals, Inc. 5.4B 88 96 60 86 89 15 1
Ascendis Pharma A/S 5.2B 48 59 77 98 62 16 1
Alkermes plc 5.0B 89 95 76 80 92 17 1
Cytokinetics, Incorporated 4.1B 63 79 89 51 69 18 1
Mirati Therapeutics, Inc. 3.8B 56 58 71 89 65 19 1
Natera, Inc. 3.6B 52 54 56 84 58 20 1
Arrowhead Pharmaceuticals, Inc. 3.4B 60 39 87 96 70 21 1
PTC Therapeutics, Inc. 2.8B 72 53 54 83 72 22 1
Insmed Incorporated 2.4B 79 80 61 89 82 23 1
ACADIA Pharmaceuticals Inc. 2.3B 61 57 98 80 72 24 1
BioCryst Pharmaceuticals, Inc. 1.9B 61 58 54 96 67 25 1
ChemoCentryx, Inc. 1.8B 84 92 97 50 87 26 1
Ironwood Pharmaceuticals, Inc. 1.8B 77 66 67 76 78 27 1
Myriad Genetics, Inc. 1.5B 50 37 82 83 59 28 1
Agios Pharmaceuticals, Inc. 1.2B 85 68 44 46 75 29 1
IVERIC bio, Inc. 1.1B 64 67 44 71 64 30 1
FibroGen, Inc. 1.0B 86 74 48 87 84 31 1
Syndax Pharmaceuticals, Inc. 1.0B 50 41 74 78 57 32 1
ImmunoGen, Inc. 946.1M 77 79 95 95 87 33 1
Enanta Pharmaceuticals, Inc. 922.8M 58 47 84 83 66 34 1
Deciphera Pharmaceuticals, Inc. 914.0M 87 79 95 91 94 35 1
Anavex Life Sciences Corp. 767.1M 69 63 74 71 72 36 1
Sangamo Therapeutics, Inc. 600.0M 85 78 93 83 91 37 1
AnaptysBio, Inc. 586.3M 80 77 92 41 80 38 1
Geron Corporation 566.2M 78 68 49 81 77 39 1
Mersana Therapeutics, Inc. 449.1M 59 69 53 92 65 40 1
Inovio Pharmaceuticals, Inc. 416.9M 67 67 92 44 71 41 1
Arbutus Biopharma Corporation 388.2M 92 93 80 87 95 42 1
Intercept Pharmaceuticals, Inc. 386.3M 87 95 98 89 96 43 1
Anika Therapeutics, Inc. 322.7M 69 67 70 51 63 44 1
Lexicon Pharmaceuticals, Inc. 321.6M 91 82 39 46 77 45 1
Precigen, Inc. 299.1M 82 75 37 85 74 46 1
bluebird bio, Inc. 288.7M 89 77 93 37 83 47 1
Rigel Pharmaceuticals, Inc. 187.5M 42 40 46 40 41 48 1
MacroGenics, Inc. 184.6M 70 53 54 46 65 49 1
Exact Sciences Corporation 7.2B 53 45 80 46 56 50 1
Amicus Therapeutics, Inc. 3.0B 81 80 71 87 85 51 1
CureVac N.V. 2.6B 87 80 90 70 90 52 1
Fate Therapeutics, Inc. 2.4B 64 52 55 48 61 53 1
Abgenix Inc. 2.1B 66 53 45 59 58 54 1
Xenon Pharmaceuticals Inc. 1.9B 82 77 87 92 89 55 1
Iovance Biotherapeutics, Inc. 1.7B 77 66 69 69 77 56 1
Xencor, Inc. 1.6B 96 95 70 95 98 57 1
Emergent BioSolutions Inc. 1.6B 70 53 87 75 75 58 1
Dynavax Technologies Corporation 1.5B 64 48 82 65 68 59 1
Ligand Pharmaceuticals Incorporated 1.5B 86 93 51 78 84 60 1
Aurinia Pharmaceuticals Inc. 1.4B 73 79 92 96 84 61 1
Veracyte, Inc. 1.4B 90 95 46 46 82 62 1
Sierra Oncology, Inc. 1.3B 47 77 38 71 52 63 1
Celldex Therapeutics, Inc. 1.3B 69 63 67 54 69 64 1
CareDx, Inc 1.2B 98 84 40 50 86 65 1
Vericel Corporation 1.1B 64 46 59 73 65 66 1
Avid Bioservices, Inc. 959.5M 80 38 40 50 66 67 1
MannKind Corporation 957.2M 77 56 43 37 66 68 1
Merus N.V. 941.6M 70 71 74 53 71 69 1
Sorrento Therapeutics, Inc. 747.5M 48 63 61 52 52 70 1
Amarin Corporation plc 734.5M 52 40 74 55 55 71 1
Catalyst Pharmaceuticals, Inc. 707.1M 77 81 98 87 87 72 1
Northwest Biotherapeutics, Inc. 682.9M 80 77 81 86 85 73 1
Organogenesis Holdings Inc. 612.1M 76 76 63 55 75 74 1
CTI BioPharma Corp. 603.6M 48 60 74 67 56 75 1
Vanda Pharmaceuticals Inc. 598.8M 66 60 87 51 69 76 1
Eagle Pharmaceuticals, Inc. 546.4M 63 40 97 92 73 77 1
Immatics N.V. 538.7M 82 95 56 99 86 78 1
Agenus Inc. 520.5M 57 43 52 77 58 79 1
Radius Health, Inc. 499.8M 64 40 37 56 57 80 1
Vaxart, Inc. 440.0M 72 56 53 38 65 81 1
Affimed N.V. 415.0M 72 57 95 43 74 82 1
ADMA Biologics, Inc. 396.6M 62 77 74 85 71 83 1
MiMedx Group, Inc. 391.5M 46 48 97 86 60 84 1
Albireo Pharma, Inc. 362.9M 59 68 41 95 63 85 1
AVEO Pharmaceuticals, Inc. 337.5M 94 87 74 83 95 86 1
Zymeworks Inc. 324.7M 52 65 45 83 57 87 1
Heron Therapeutics, Inc. 314.6M 66 74 61 84 71 88 1
Silence Therapeutics plc 313.4M 68 66 72 69 69 89 1
AC Immune SA 299.8M 66 77 79 63 68 90 1
Viridian Therapeutics, Inc. 293.2M 72 87 43 45 65 91 1
Sutro Biopharma, Inc. 245.5M 83 67 64 50 74 92 1
Chimerix, Inc. 178.4M 80 84 95 47 83 93 1
DermTech, Inc. 165.3M 60 51 45 86 58 94 1
Gelesis Holdings, Inc. 111.5M 64 90 92 98 80 95 1
Brooklyn ImmunoTherapeutics, Inc. 31.8M 58 72 43 71 58 96 1
INSYS Therapeutics, Inc. 3.2M 75 78 87 52 73 97 1

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