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Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. Announces Additional Positive Interim Data from an Ongoing Phase 1 Study of Their Lead Investigational in Vivo Genome Editing Candidate, NTLA-2001

2022-06-24 11:31:00

Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. announced additional positive interim data from an ongoing Phase 1 study of their lead investigational in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin (ATTR) amyloidosis. The data were presented in an oral presentation at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022, taking place June 22 – 26 in London. The presentation included extended follow-up data from 15 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) treated across four single-ascending dose cohorts in Part 1 of the study. Results demonstrated sustained durability of serum transthyretin (TTR) reduction through the last measured timepoint in the ongoing observation. These data support NTLA-2001’s continued development as a potential one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein. At the highest dose evaluated, treatment with NTLA-2001 at 1.0 mg/kg resulted in a 93% mean and 98% maximum serum TTR reduction by day 28 across the six patients treated. With longer-term follow-up data now available, these deep reductions continue to be sustained through six months, with an observed mean reduction of 93%. Additionally, three patients in the 1.0 mg/kg cohort have reached nine months in the follow-up period with no evidence of a loss in TTR reduction after a single dose. In the 0.7 mg/kg dose cohort, the 86% mean serum TTR reduction observed at day 28 also remained durable through six months. Further, in the 0.1 and 0.3 mg/kg cohorts, patients have now reached 12 months of follow-up, and a durable response to treatment continues to be observed. Notably, patients in the 0.3 mg/kg cohort sustained an 89% mean serum TTR reduction at 12 months. At all four dose levels, NTLA-2001 was generally well tolerated through the follow-up period (median follow-up of 10 months). The majority of adverse events were mild in severity with 73% (n = 11) of patients reporting a maximal adverse event severity of Grade 1. There was a single possibly related serious adverse event of vomiting (Grade 3) reported in a patient with concomitant medical history of gastroparesis in the 1.0 mg/kg dose group. The most frequent adverse events included headache, infusion-related reactions, back pain, rash and nausea. All infusion-related reactions were considered mild, resolving without clinical sequelae. The safety and activity profile of NTLA-2001 observed in Part 1 indicates that NTLA-2001 has a favorable therapeutic window. These data combined with pharmacokinetic modeling and simulation data support the utilization of a fixed dose of 80 mg in Part 2, which is anticipated to yield similar exposures to the 1.0 mg/kg dose. Dosing is ongoing in Part 2, the single-dose expansion cohort of the polyneuropathy arm. The Phase 1 study, run by Intellia as the program’s development and commercialization lead as part of a multi-target collaboration with Regeneron, is evaluating NTLA-2001 in patients with either ATTRv-PN or ATTR amyloidosis with cardiomyopathy (ATTR-CM). The cardiomyopathy arm, evaluating NTLA-2001 across patients classified with New York Heart Association (NYHA) Class I - III heart failure, is ongoing. The companies plan to present the first interim data from the cardiomyopathy arm in the second half of 2022. Enrollment across both ATTRv-PN and ATTR-CM patient populations is expected to complete in 2022.

Regeneron Pharmaceuticals, Inc.(NasdaqGS:REGN) added to Russell 1000 Dynamic Index

2022-06-24 00:00:00

Regeneron Pharmaceuticals, Inc.(NasdaqGS:REGN) added to Russell 1000 Dynamic Index

Regeneron Pharmaceuticals, Inc. Presents at 5th LSX USA Congress & CEO Forums, Jun-21-2022 03:50 PM

2022-06-16 19:39:00

Regeneron Pharmaceuticals, Inc. Presents at 5th LSX USA Congress & CEO Forums, Jun-21-2022 03:50 PM. Venue: Boston, United States. Speakers: Nouhad Husseini, Senior Vice President of Business Development.

Regeneron Pharmaceuticals, Inc., and Sanofi Biotechnology, Enters into the Amended and Restated Immuno-Oncology License and Collaboration Agreement

2022-06-02 11:37:00

A&R IO License and Collaboration Agreement. On June 1, 2022, Regeneron Pharmaceuticals, Inc., a New York corporation, and Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France, entered into the Amended and Restated Immuno-Oncology License and Collaboration Agreement (the “ A&R IO LCA”), which amends the Immuno-Oncology License and Collaboration Agreement, dated as of July 1, 2015 and executed as of July 27, 2015 (as amended), by and between the Company and Sanofi Biotechnology (the “ Original IO LCA”). The A&R IO LCA is subject to and will become effective on the first day of the first month following receipt of all necessary authorizations and expiration of all necessary waiting periods applicable to the consummation of the A&R IO LCA (such date, the “ A&R Effective Date”). The Original IO LCA provides for Regeneron and Sanofi Biotechnology to collaborate on the development and commercialization of certain immuno-oncology products, including Libtayo® (cemiplimab). From and after the A&R Effective Date, Regeneron will have the sole right to develop and commercialize Libtayo worldwide and no other products will be subject to the A&R IO LCA; and Regeneron will also obtain a license under certain intellectual property rights of Sanofi Biotechnology to develop and commercialize Libtayo worldwide and Sanofi Biotechnology will transfer to Regeneron certain regulatory, promotional, and other rights relating to the commercialization of Libtayo outside the United States. The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi Biotechnology will perform for Regeneron certain transition, distribution, and manufacturing services, respectively. Under the A&R IO LCA, the quarterly period ended March 31, 2022 is the last quarter for which Sanofi Biotechnology and Regeneron share net profits and losses for Libtayo under the Original IO LCA. From and after April 1, 2022 (after giving effect to certain true-up payments as set forth in the A&R IO LCA), Regeneron will be entitled to all profits from Libtayo and will pay Sanofi Biotechnology an 11% royalty on net product sales of Libtayo through March 31, 2034. In addition, the A&R IO LCA provides for the following payments by Regeneron to Sanofi Biotechnology: (i) a $900 million upfront payment, payable within 10 business days after the A&R Effective Date; (ii) a $100 million development milestone payment upon the first marketing approval from the U.S. Food and Drug Administration or the European Commission of Libtayo in non-small cell lung cancer in combination with chemotherapy; and (iii) sales milestone payments of up to $100 million in the aggregate upon achieving certain amounts of worldwide net product sales of Libtayo in 2022 or 2023.

Regeneron Pharmaceuticals, Inc. - Special Call

2022-06-02 11:30:00

To discuss the company's purchase of Sanofi's stake in the Regeneron and Sanofi collaboration on Libtayo(R) (cemiplimab), a PD-1 Inhibitor Approved for Multiple Forms of Cancer

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) agreed to acquire Worldwide Exclusive License Rights of Libtayo from Sanofi Biotechnology for $1.1 billion.

2022-06-02 00:00:00

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) agreed to acquire Worldwide Exclusive License Rights of Libtayo from Sanofi Biotechnology for $1.1 billion on June 1, 2022. Under the terms of the amended and restated immuno-oncology license and collaboration agreement, Sanofi will transfer the rights to develop, commercialize, and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period. In exchange, Sanofi will receive an upfront payment of $900 million, and an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment upon the first approval by either the FDA or European Commission of Libtayo in combination with chemotherapy for first-line treatment of certain patients with NSCLC, as well as sales-related milestone payments of up to $100 million in total over the next two years. The transaction is subject to clearance under competition law and is expected to close in the third quarter of 2022.

FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis

2022-05-31 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules). The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis (PRIME2 and PRIME). Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn). Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric atopic dermatitis (6 months to 5 years of age), prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve breathing. DUPIXENT may also help reduce the amount of oral corticosteroids need while preventing severe asthma attacks and improving breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age. to treat adults and children 12 years of age and older, who weigh at least 88 pounds (40 kg), with eosinophilic esophagitis (EoE). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 12 years of age and who weigh at least 88 pounds (40 kg). Important safety information for U.S. Patients: Do not use if are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell healthcare provider about all medical conditions, including if you: have eye problems; have a parasitic (helminth) infection; are scheduled to receive any vaccinations. Should not receive a "live vaccine" right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. Tell healthcare provider about all the medicines take, including prescription and over-the- counter medicines, vitamins and herbal supplements. DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell healthcare provider or get emergency help right away if get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in stomach-area. Asthma: injection site reactions, pain in the throat (oropharyngeal pain), high count of a certain white blood cell (eosinophilia), and parasitic (helminth) infections. Chronic rhinosinusitis with nasal polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia). Eosinophilic esophagitis: injection site reactions, upper respiratory tract infections, cold sores in mouth or on lips, and joint pain (arthralgia). Tell healthcare provider if have any side effect that bothers or that does not go away.

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) completed the acquisition of Checkmate Pharmaceuticals, Inc. (NasdaqGM:CMPI) from Decheng Capital China Life Sciences USD Fund III, L.P., a fund managed by Decheng Capital LLC, Arthur Krieg and others.

2022-05-27 00:00:00

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) entered into a definitive agreement to acquire Checkmate Pharmaceuticals, Inc. (NasdaqGM:CMPI) from Decheng Capital China Life Sciences USD Fund III, L.P., a fund managed by Decheng Capital LLC, Arthur Krieg and others for approximately $250 million on April 18, 2022. As per the terms of the transaction, Regeneron shall acquire all outstanding shares of Checkmate at an all-cash price of $10.50 per share. The Offer will initially remain open for 20 business days, subject to extension under certain circumstances. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger. Checkmate Pharmaceuticals shall be delisted from NASDAQ post deal completion. Checkmate shall pay a termination fee of $8.75 million to Regeneron, equivalent to 3.5%. Regeneron currently has, and will have, available to them, through a variety of sources, including cash on hand, funds necessary for the payment of the aggregate Offer Price and the aggregate Merger Consideration (as defined below) and to satisfy all of their payment obligations under the Merger Agreement and resulting from the transactions contemplated thereby. Regeneron has not entered into any financing commitment in connection with the Merger Agreement or the transactions contemplated thereby. The closing of the tender offer will be subject to certain conditions, including the tender of at least one more share than 50% of the outstanding shares of Checkmate common stock, approval by the shareholders of Checkmate Pharmaceuticals, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The Offer is not subject to a financing condition. The transaction was unanimously by the Board of Directors of Checkmate Pharmaceuticals and approved by the Board of Directors of Regeneron Pharmaceuticals. On May 10, 2022, the waiting period applicable to the Offer under the HSR Act expired. On May 2, 2022, Regeneron commenced the Offer and Checkmate filed the Schedule 14D-9. The tender offer will close on May 27, 2022. As of May 4, 2022, the transaction is expected to close in mid-2022. Andrew R. Brownstein, Victor Goldfeld and John L. Robinson of Wachtell, Lipton, Rosen & Katz acted as legal advisors to Regeneron Pharmaceuticals. Centerview Partners is acting as Checkmate’s financial advisor and fairness opinion provider while Stuart M. Cable, Mitchell S. Bloom, Robert Masella, Ben Marsh, Arman Oruc, Simone Waterbury, Kirby Lewis, Elliot Silver, Carl Metzger, Brian Mukherjee, Sarah Bock, Monica Patel, Jennifer Fay, Julie Tibbets, Roger A. Cohen, Dan Karelitz, Olivia D. Uitto, Deborah Birnbach, Nathan Brodeur, Jacqueline Klosek, Jacob R. Osborn and Andrew H. Goodman of Goodwin Procter LLP is serving as legal advisors. Roy Tannenbaum and Philip Richter of Fried, Frank, Harris, Shriver & Jacobson LLP acted as legal advisors to Centerview Partners LLC. Regeneron has retained Innisfree M&A Incorporated to be the Information Agent and Broadridge Corporate Issuer Solutions, Inc. to be the Depository in connection with the Offer. In connection with Centerview’s services as a financial advisor to Checkmate, Checkmate has agreed to pay Centerview an aggregate fee of, approximately, $6.25 million, $1 million of which was payable upon the rendering of Centerview’s opinion and $5.25 million of which is payable contingent upon consummation of the Transactions. In addition, Checkmate has agreed to reimburse certain of Centerview’s expenses arising, and to indemnify Centerview against certain liabilities that may arise, out of Centerview’s engagement. Centerview Partners has been engaged formally on February 10, 2022 by Checkmate Pharmaceuticals to provide its services on the offer. Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) completed the acquisition of Checkmate Pharmaceuticals, Inc. (NasdaqGM:CMPI) from Decheng Capital China Life Sciences USD Fund III, L.P., a fund managed by Decheng Capital LLC, Arthur Krieg and others on May 27, 2022. As of the tender offer expiration, a total of 18.47 million shares had been validly tendered and not validly withdrawn, representing approximately 83.8% of the outstanding shares. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger. All conditions to the Offer were satisfied or waived. Promptly after the expiration of the Offer, Regeneron accepted for payment all of the Shares validly tendered and not validly withdrawn pursuant to the Offer.

Regeneron Pharmaceuticals, Inc. Presents at Tumor Myeloid Microenvironment Directed Therapeutics, Jun-15-2022 03:30 PM

2022-05-24 13:17:00

Regeneron Pharmaceuticals, Inc. Presents at Tumor Myeloid Microenvironment Directed Therapeutics, Jun-15-2022 03:30 PM. Venue: Boston, Massachusetts, United States. Speakers: Roy Noy, Senior Staff Scientist.

patientNOW, Inc, Rx Marketing Group, 17th Edition of the Music City Symposium for Cosmetic Advances & Laser Education, May 11, 2022 through May 15, 2022

2022-05-05 12:30:00

patientNOW, Inc, Rx Marketing Group, 17th Edition of the Music City Symposium for Cosmetic Advances & Laser Education, May 11, 2022 through May 15, 2022. Venue: Nashville, Tennessee, United States.

Tranche Update on Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN)'s Equity Buyback Plan announced on November 12, 2021.

2022-05-04 07:17:00

From January 1, 2022 to March 31, 2022, the company has repurchased 566,973 shares, representing 0.53% for $352 million. With this, the company has completed the repurchase of 810,957 shares, representing 0.77% for $509.08 million under the buyback announced on November 12, 2021.

Regeneron Pharmaceuticals, Inc. Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 08:40 AM

2022-05-02 20:15:00

Regeneron Pharmaceuticals, Inc. Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 08:40 AM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Hanson Wade Limited, Novel Format Conjugates Summit, Apr 25, 2022 through Apr 27, 2022

2022-04-27 00:22:00

Hanson Wade Limited, Novel Format Conjugates Summit, Apr 25, 2022 through Apr 27, 2022. Venue: Omni Parker House, 60 School St, Boston, Massachusetts, United States.

Regeneron Pharmaceuticals, Inc. Presents at Novel Format Conjugates Summit, Apr-25-2022

2022-04-27 00:22:00

Regeneron Pharmaceuticals, Inc. Presents at Novel Format Conjugates Summit, Apr-25-2022 . Venue: Omni Parker House, 60 School St, Boston, Massachusetts, United States.

Regeneron Pharmaceuticals, Inc. Presents at Outsourcing in Clinical Trials East Coast 2022, May-24-2022

2022-04-24 13:44:00

Regeneron Pharmaceuticals, Inc. Presents at Outsourcing in Clinical Trials East Coast 2022, May-24-2022 . Venue: King Of Prussia, Pennsylvania, United States. Speakers: Bari Kowal, Senior VP of Development Operations & Portfolio Planning.

Arena International Management Limited, Outsourcing in Clinical Trials East Coast 2022, May 24, 2022 through May 25, 2022

2022-04-24 09:19:00

Arena International Management Limited, Outsourcing in Clinical Trials East Coast 2022, May 24, 2022 through May 25, 2022. Venue: King Of Prussia, Pennsylvania, United States.

Regeneron Pharmaceuticals, Inc. Presents at PEGS Boston Conference 2022, May-02-2022 through May-06-2022

2022-04-23 07:37:00

Regeneron Pharmaceuticals, Inc. Presents at PEGS Boston Conference 2022, May-02-2022 through May-06-2022. Venue: Boston, Massachusetts, United States. Presentation Date & Speakers: May-03-2022, Eric Smith, Senior Director, Bispecifics. May-05-2022, Andres Perez Bay, Senior Staff Scientist, Oncology & Angiogenesis.

SpringWorks Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Regeneron to Evaluate Nirogacestat in Combination with Regn5458 in Patients with Relapsed or Refractory Multiple Myeloma

2022-04-19 10:30:00

SpringWorks Therapeutics, Inc. announced that the company has entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with Regeneron’s investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, REGN5458, in patients with relapsed or refractory multiple myeloma. Gamma secretase inhibition helps prevent the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase levels of membrane-bound BCMA and reduce levels of soluble BCMA, thereby helping to enhance the activity of BCMA-targeted therapies, including CD3 bispecific antibodies. Under the terms of the agreement, Regeneron is responsible for the clinical development and will assume all costs associated with the study, other than expenses related to the manufacturing and supply of nirogacestat and certain expenses related to intellectual property rights.

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) entered into a definitive agreement to acquire Checkmate Pharmaceuticals, Inc. (NasdaqGM:CMPI) from Decheng Capital China Life Sciences USD Fund III, L.P., a fund managed by Decheng Capital LLC, Arthur Krieg and others for approximately $250 million.

2022-04-19 00:00:00

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) entered into a definitive agreement to acquire Checkmate Pharmaceuticals, Inc. (NasdaqGM:CMPI) from Decheng Capital China Life Sciences USD Fund III, L.P., a fund managed by Decheng Capital LLC, Arthur Krieg and others for approximately $250 million on April 18, 2022. As per the terms of the transaction, Regeneron shall acquire all outstanding shares of Checkmate at an all-cash price of $10.50 per share. The Offer will initially remain open for 20 business days, subject to extension under certain circumstances. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger. Checkmate Pharmaceuticals shall be delisted from NASDAQ post deal completion. Checkmate shall pay a termination fee of $8.75 million to Regeneron, equivalent to 3.5%. Regeneron currently has, and will have, available to them, through a variety of sources, including cash on hand, funds necessary for the payment of the aggregate Offer Price and the aggregate Merger Consideration (as defined below) and to satisfy all of their payment obligations under the Merger Agreement and resulting from the transactions contemplated thereby. Regeneron has not entered into any financing commitment in connection with the Merger Agreement or the transactions contemplated thereby. The closing of the tender offer will be subject to certain conditions, including the tender of at least one more share than 50% of the outstanding shares of Checkmate common stock, approval by the shareholders of Checkmate Pharmaceuticals, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The Offer is not subject to a financing condition. The transaction was unanimously by the Board of Directors of Checkmate Pharmaceuticals and approved by the Board of Directors of Regeneron Pharmaceuticals. On May 10, 2022, the waiting period applicable to the Offer under the HSR Act expired. On May 2, 2022, Regeneron commenced the Offer and Checkmate filed the Schedule 14D-9. The tender offer will close on May 27, 2022. As of May 4, 2022, the transaction is expected to close in mid-2022. Andrew R. Brownstein, Victor Goldfeld and John L. Robinson of Wachtell, Lipton, Rosen & Katz acted as legal advisors to Regeneron Pharmaceuticals. Centerview Partners is acting as Checkmate’s financial advisor and fairness opinion provider while Stuart M. Cable, Mitchell S. Bloom, Robert Masella, Ben Marsh, Arman Oruc, Simone Waterbury, Kirby Lewis, Elliot Silver, Carl Metzger, Brian Mukherjee, Sarah Bock, Monica Patel, Jennifer Fay, Julie Tibbets, Roger A. Cohen, Dan Karelitz, Olivia D. Uitto, Deborah Birnbach, Nathan Brodeur, Jacqueline Klosek, Jacob R. Osborn and Andrew H. Goodman of Goodwin Procter LLP is serving as legal advisors. Roy Tannenbaum and Philip Richter of Fried, Frank, Harris, Shriver & Jacobson LLP acted as legal advisors to Centerview Partners LLC. Regeneron has retained Innisfree M&A Incorporated to be the Information Agent and Broadridge Corporate Issuer Solutions, Inc. to be the Depository in connection with the Offer. In connection with Centerview’s services as a financial advisor to Checkmate, Checkmate has agreed to pay Centerview an aggregate fee of, approximately, $6.25 million, $1 million of which was payable upon the rendering of Centerview’s opinion and $5.25 million of which is payable contingent upon consummation of the Transactions. In addition, Checkmate has agreed to reimburse certain of Centerview’s expenses arising, and to indemnify Centerview against certain liabilities that may arise, out of Centerview’s engagement. Centerview Partners has been engaged formally on February 10, 2022 by Checkmate Pharmaceuticals to provide its services on the offer.

Regeneron Pharmaceuticals, Inc. Presents at 4th Longevity Leaders World Congress, Apr-26-2022 through Apr-27-2022

2022-04-14 18:15:00

Regeneron Pharmaceuticals, Inc. Presents at 4th Longevity Leaders World Congress, Apr-26-2022 through Apr-27-2022. Venue: etc. venues, 133 Houndsditch, Liverpool Street, London, United Kingdom. Presentation Date & Speakers: Apr-26-2022, Tea Shavlakadze, Director of Aging/Age-Related disorders. Apr-27-2022, Tea Shavlakadze, Director of Aging/Age-Related disorders.

Regeneron Pharmaceuticals, Inc. Announces U.S. FDA Extends Review of Biologics License Application for Regen-Cov(R) (Casirivimab and Imdevimab) for Treatment and Prophylaxis of Covid-19

2022-04-14 11:00:00

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA considers the submission of these additional data to be a Major Amendment to the BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies to complete its review of the current BLA at this time. REGEN-COV, an investigational monoclonal antibody therapy, first became available to U.S. patients in November 2020, via the FDA's Emergency Use Authorization (EUA) process for medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. In January 2022, FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. Therefore, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions. Regeneron remains committed to fighting this pandemic and believes that monoclonal antibody therapies will continue to play an important role. The company is progressing investigational next generation antibodies that are active against the currently circulating variants of concern, and has initiated a first-in-human clinical trial of one of these next generation antibodies. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

ViGeneron GmbH Signs Gene Therapy Strategic Collaboration and Option Agreement with Regeneron for One Inherited Retinal Disease Target

2022-04-06 07:00:00

ViGeneron GmbH announced a target-specific strategic collaboration and option agreement with Regeneron Pharmaceuticals Inc. to develop and commercialize a gene therapy product based on ViGeneron’s novel engineered recombinant adeno-associated virus vectors (vgAAVs) to treat an inherited retinal disease (IRD). Under the terms of the research collaboration, Regeneron and ViGeneron will create and validate vgAAV-based therapeutic candidates for one undisclosed IRD target. ViGeneron receives an upfront payment and research funding. Regeneron has an option for an exclusive license to develop, commercialize and manufacture the vgAAV-based product for the specific target. ViGeneron is eligible to receive an option exercise fee, development and commercial milestone payments, plus royalties on net sales. ViGeneron’s vgAAV vector platform is designed to overcome the limitations of existing adeno-associated virus (AAV)-based gene therapies. To date, therapeutically impactful targeting of photoreceptors relies on subretinal vector delivery, which harbors substantial risks of retinal detachment and collateral damage, often without achieving widespread photoreceptor transduction. vgAAV vectors could potentially enable the efficient transduction of target cells via intravitreal injection that allows lateral spreading and minimizes the risk of retinal detachment caused by conventional subretinal injection.

Regeneron Pharmaceuticals, Inc., Q1 2022 Earnings Call, May 04, 2022

2022-04-05 20:05:00

Regeneron Pharmaceuticals, Inc., Q1 2022 Earnings Call, May 04, 2022

Regeneron Pharmaceuticals, Inc. to Report Q1, 2022 Results on May 04, 2022

2022-04-05 20:05:00

Regeneron Pharmaceuticals, Inc. announced that they will report Q1, 2022 results Pre-Market on May 04, 2022

Regeneron Pharmaceuticals, Inc. - Shareholder/Analyst Call

2022-04-01 14:42:00

Annual Meeting of Shareholders

Regeneron Pharmaceuticals, Inc., Annual General Meeting, Jun 10, 2022

2022-04-01 14:42:00

Regeneron Pharmaceuticals, Inc., Annual General Meeting, Jun 10, 2022, at 10:30 US Eastern Standard Time. Agenda: To elect four Class I directors for a three-year term; to ratify the appointment of PricewaterhouseCoopers LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2022; to cast an advisory vote to approve the compensation of the Company's Named Executive Officers as disclosed in these proxy materials (say-on-pay); and to act upon such other matters as may properly come before the meeting and any adjournment(s) or postponement(s) thereof.

Regeneron Pharmaceuticals, Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 01:20 PM

2022-03-23 02:30:00

Regeneron Pharmaceuticals, Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 01:20 PM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Justin Holko, Vice President of Investor Relations, Robert E. Landry, Executive VP of Finance & CFO.

Hanson Wade Limited, Tumor Myeloid Microenvironment Directed Therapeutics, Jun 14, 2022 through Jun 16, 2022

2022-02-28 18:16:00

Hanson Wade Limited, Tumor Myeloid Microenvironment Directed Therapeutics, Jun 14, 2022 through Jun 16, 2022. Venue: Boston, Massachusetts, United States.

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.

Regeneron Presents Encouraging Phase 2 Results for High-dose Aflibercept 8 mg in Wet Age-related Macular Degeneration at Angiogenesis Meeting

2022-02-11 12:50:00

Regeneron Pharmaceuticals, Inc. announced results from its Phase 2 proof-of-concept trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The results will be presented at the Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2022 annual meeting on February 12. As previously announced, more patients treated with aflibercept 8 mg had no retinal fluid at week 16, when the primary efficacy endpoint was assessed. At this timepoint, 43% (n=23/53) had no fluid in the macula compared to 26% for EYLEA (n=14/53) (p=0.0667); and 51% (n=27) had no fluid in the center subfield compared to 34% for EYLEA (n=18) (p=0.0770). At week 16, patients in both treatment groups had received three initial doses (administered at weeks 0, 4 and 8), after which dosing was extended to every 12 weeks. In new results presented for the first time, aflibercept 8 mg continued to show numeric improvements in anatomical and vision outcomes compared to EYLEA through 44 weeks. Eyes treated with aflibercept 8 mg were more likely to be dry in the center subfield on optical coherence tomography (OCT) compared to EYLEA at every timepoint measured throughout the trial after the initial monthly dosing period. At week 44 when the trial ended, key anatomical and vision changes included: 40% (n=21/53) of patients treated with aflibercept 8 mg did not have fluid in the center subfield compared to 28% (n=15/53) of patients treated with EYLEA (nominal p=0.2185). Twice as many patients treated with aflibercept 8 mg (32%, n=17/53) had no macular fluid compared to patients treated with EYLEA (15%, n=8/53) (nominal p=0.0395), as measured by spectral domain OCT. Measuring macular fluid provides an evaluation of a larger area of the retina compared to the center subfield and may provide a better understanding of the anatomical effects of treatment in wet AMD. 7.9 average letter improvement from baseline in the aflibercept 8 mg group, compared to 5.1 letters in the EYLEA group, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters (nominal p=0.1957). Nearly half (47%) of aflibercept 8 mg patients achieved at least a 10-letter gain (2 lines on a vision test) and more than a quarter (28%) achieved more than 15 letters (3 lines on a vision test), compared to 35% and 18% for patients treated with EYLEA, respectively. Through 44 weeks, adverse events (AEs) in the study eye occurred in 38% (n=20/53) of both aflibercept 8 mg and EYLEA patients. There were no serious AEs of intraocular inflammation (including occlusive retinal vasculitis), and no anti-platelet trialists' collaboration (APTC)-defined arterial thromboembolic events. The most common ocular AEs that occurred more frequently in the aflibercept 8 mg group were vitreous detachment (4 aflibercept 8 mg, 2 EYLEA), conjunctival hemorrhage (3 aflibercept 8 mg, 2 EYLEA) and retinal tear (2 aflibercept 8 mg, 0 EYLEA). There was one patient death in the aflibercept 8 mg unrelated to treatment. Wet AMD is the leading cause of vision loss among people 50 years and older in the U.S. Existing anti-VEGF treatments including EYLEA have helped change the course of disease for millions of patients worldwide, and efforts to develop new medicines are focused on further enhancing clinical effectiveness while extending the time between treatment doses. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer. This new, concentrated high-dose aflibercept formulation enables a greater amount of medicine to be administered with each treatment, and could potentially extend the time between doses while retaining the efficacy and safety profile seen with EYLEA. Aflibercept 8 mg is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

FDA Accepts Dupixent® (Dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-To-Severe Atopic Dermatitis

2022-02-10 06:00:00

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. Atopic dermatitis is a chronic type 2 inflammatory skin disease, and 85 to 90% of patients develop symptoms (onset of disease) before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, and crusting and oozing, along with increased risk of skin infections. Moderate-to-severe atopic dermatitis may also significantly impact the quality of life of a young child, their parents and caregivers. Current treatment options in this age group are primarily topical steroids, which can be associated with safety risks and may impair growth when used long-term. The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone. Safety results were generally consistent with the safety profile of Dupixent in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with Dupixent included conjunctivitis and herpes viral infections. The use of Dupixent in children younger than 6 years of age with moderate-to-severe atopic dermatitis is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years).

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

2022-02-08 07:31:00

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

Regeneron Pharmaceuticals, Inc. Presents at SLAS 2022 International Conference and Exhibition, Feb-09-2022 01:00 PM

2022-02-05 10:28:00

Regeneron Pharmaceuticals, Inc. Presents at SLAS 2022 International Conference and Exhibition, Feb-09-2022 01:00 PM. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States. Speakers: Peter Hawkins.

Sanofi and Regeneron Announces European Medicines Agency’s Committee for Medicinal Products Recommends Approval of Dupixent® (Dupilumab) for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

2022-02-04 18:29:00

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending to extend the approval of Dupixent® (dupilumab) in the European Union to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to11 years. Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children’s developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports. On October 20, 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved.

Regeneron Pharmaceuticals, Inc. Presents at SCOPE Summit 2022, Feb-07-2022 through Feb-10-2022

2022-02-03 10:27:00

Regeneron Pharmaceuticals, Inc. Presents at SCOPE Summit 2022, Feb-07-2022 through Feb-10-2022. Venue: Orlanda, Florida, United States. Presentation Date & Speakers: Feb-08-2022, Cynthia Pan, Senior Director, Program Operations Leader, Global Clinical Operations, Rinol Alaj, Director, Head of COA and Patient Innovation. Feb-10-2022, Christine Enciso, Vice President, Development Services and Operational Excellence.

Regeneron Pharmaceuticals, Inc. and Sanofi Announce Positive Dupixent® (dupilumab) Data Across Five Diseases with Underlying Type 2 Inflammation to be Presented at 2022 AAAAI Annual Meeting

2022-02-01 21:29:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced positive Dupixent® (dupilumab) data across five diseases with underlying type 2 inflammation will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting from February 25 to 28. The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Additionally, positive results from two Phase 3 trials in a sixth indication, prurigo nodularis, were recently announced and will be presented at a separate medical meeting later this year. Abstracts being presented at the AAAAI meeting have been published in an online supplement to The Journal of Allergy and Clinical Immunology and include: Late-breaking Abstracts: New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. The use of Dupixent in these diseases is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. Oral Presentation L01 (February 26, 2:00-3:15 pm MST): Dupilumab Significantly Reduces Itch and Hives in Patients with Chronic Spontaneous Urticaria: Results from a Phase 3 Trial (LIBERTY-CSU CUPID Study A), Marcus Maurer; Oral Presentation L02 (February 26, 2:00-3:15 pm MST): Dupilumab Improves Clinical and Histologic Aspects of Disease in Adult and Adolescent Patients with Eosinophilic Esophagitis at Week 24: Results from Part B of the 3-Part LIBERTY EoE TREET Study, Marc Rothenberg and Evan Dellon. Asthma: New analyses evaluate Dupixent in patients aged six years and older with moderate-to-severe asthma. These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations. Oral Presentation 189 (February 26, 2:00-3:15 pm MST): Long-Term Efficacy of Dupilumab in Patients with Asthma with and without Comorbid Chronic Rhinosinusitis/Nasal Polyposis, Andrew Menzies-Gow; Oral Presentation 190 (February 26, 2:00-3:15 pm MST): Efficacy of Dupilumab in the Prevention of Seasonal Exacerbations in Patients with and without Evidence of an Allergic Asthma Phenotype, Anju Peters; Poster 42 (February 26, 9:45-10:45 am MST): Dupilumab Efficacy in LIBERTY ASTHMA QUEST Patients with Uncontrolled, Moderate-to-Severe Asthma by Allergen Sensitization Status, Jonathan Corren; Poster 50 (February 26, 9:45-10:45 am MST): Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarkers in Children with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE, Leonard Bacharier; Poster 409 (February 27, 2:00-3:15 pm MST): Dupilumab Improves Asthma Control, and Allergic Rhinitis-Related Health-Related Quality of Life in Children with Uncontrolled Persistent Asthma with Comorbid Allergic Rhinitis, Alessandro Fiocchi; Poster 571 (February 28, 9:45-10:45 am MST): Long-Term Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarker Patients with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE, Michael Wechsler.

Regeneron Pharmaceuticals, Inc. and Sanofi Adopts Positive Opinion, Recommending to Extend the Approval of Dupixent

2022-01-31 05:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to 11 years. Dupixent is currently approved in Europe for adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with high-dose ICS plus another medicinal product for maintenance treatment. It is also approved in the U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally.

Regeneron Pharmaceuticals, Inc. and Sanofi Provides Regulatory Update on Libtayo® (Cemiplimab-Rwlc) in Advanced Cervical Cancer

2022-01-28 12:00:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo® (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the U.S. Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing.

Regeneron Pharmaceuticals, Inc. Presents at 18th Annual WORLDSymposium, Feb-07-2022 through Feb-11-2022

2022-01-28 07:11:00

Regeneron Pharmaceuticals, Inc. Presents at 18th Annual WORLDSymposium, Feb-07-2022 through Feb-11-2022. Venue: San Diego, California, United States. Presentation Date & Speakers: Feb-10-2022, Elizabeth Hwang-Wong, Maria Praggastis.

WORLDSymposia Ltd, 18th Annual WORLDSymposium, Feb 07, 2022 through Feb 11, 2022

2022-01-18 10:00:00

WORLDSymposia Ltd, 18th Annual WORLDSymposium, Feb 07, 2022 through Feb 11, 2022. Venue: San Diego, California, United States. To discuss lysosomal storage diseases.

Regeneron Pharmaceuticals, Inc. to Report Q4, 2021 Results on Feb 04, 2022

2022-01-13 21:05:00

Regeneron Pharmaceuticals, Inc. announced that they will report Q4, 2021 results Pre-Market on Feb 04, 2022

Regeneron Pharmaceuticals, Inc., Q4 2021 Earnings Call, Feb 04, 2022

2022-01-13 21:05:00

Regeneron Pharmaceuticals, Inc., Q4 2021 Earnings Call, Feb 04, 2022

Cambridge Innovation Institute, LLC, PEGS Boston Conference 2022, May 02, 2022 through May 06, 2022

2022-01-13 18:45:00

Cambridge Innovation Institute, LLC, PEGS Boston Conference 2022, May 02, 2022 through May 06, 2022. Venue: Boston, Massachusetts, United States.

Society for Laboratory Automation & Screening, SLAS 2022 International Conference and Exhibition, Feb 05, 2022 through Feb 09, 2022

2021-12-28 18:17:00

Society for Laboratory Automation & Screening, SLAS 2022 International Conference and Exhibition, Feb 05, 2022 through Feb 09, 2022. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States.

Regeneron Pharmaceuticals, Inc. Presents at 63rd American Society of Hematologists Annual Meeting & Exposition, Dec-13-2021 04:30 PM

2021-12-13 19:11:00

Regeneron Pharmaceuticals, Inc. Presents at 63rd American Society of Hematologists Annual Meeting & Exposition, Dec-13-2021 04:30 PM. Venue: Georgia World Congress Center, Atlanta, Georgia, United States.

Regeneron Pharmaceuticals, Inc. Announces New Results for Higher Dose Level Cohorts of Its Investigational REGN5458 (BCMAxCD3) Bispecific Antibody

2021-12-11 17:00:00

Regeneron Pharmaceuticals, Inc. announced new results for higher dose level cohorts of its investigational REGN5458 (BCMAxCD3) bispecific antibody, which were presented in an oral session at the 2021 American Society of Hematology (ASH) Annual Meeting in Atlanta, GA. The new results from the Phase 1 portion of the Phase 1/2 trial in patients with relapsed/refractory multiple myeloma found a 51% overall response rate (ORR) across all dose groups, rising to 75% in patients who received higher doses of REGN5458 (200-800 mg). REGN5458 is a bispecific antibody designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T-cells in order to bridge them together and activate T-cells to kill the cancer cells. It is currently being assessed in the potentially registrational Phase 2 portion of the trial, which is expected to complete recruitment in 2022. In results presented at ASH December 11, 2021, 73 patients were treated with REGN5458 doses ranging from 3-800 mg for up to 21 months at the time of data cutoff. Patients had received a median of 5 prior lines of therapy, with 38% (n=28) being penta-refractory and 90% (n=66) being refractory to the last line of therapy. The ORR was 75% at the highest dose levels (200-800 mg, n=18/24), and 51% among all enrolled patients (n=37/73). Most responses occurred within the first month of treatment and deepened over time. Among responders across all dose groups: 86% (n=32/37) achieved a very good partial response (VGPR) or better. 43% (n=16/37) achieved a complete response (CR), with 40% of evaluable CR patients (n=4/10) being minimal residual disease (MRD) negative. 8 months from the time of response, there was a 90% probability of being event-free (95% CI: 73%, 97%), defined by the absence of disease progression or death. The estimated median duration of response had not yet been reached at the time of data cutoff. Responses occurred rapidly, usually within the first month of treatment, and continue to deepen with longer treatment; the higher dose groups currently have substantially shorter follow up.

Regeneron Pharmaceuticals, Inc. - Special Call

2021-12-06 20:20:00

Regeneron Pharmaceuticals, Inc. - Special Call

Confo Therapeutics Enters into Collaborative Agreement with Regeneron Pharmaceuticals, Inc

2021-11-30 10:00:00

Confo Therapeutics announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies – to stabilize GPCRs (G protein-coupled receptors) in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the large and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs.

Nykode Therapeutics Enters into Collaboration Agreement with Regeneron to Develop Innovative Vaccines Against Cancer and Infectious Diseases

2021-11-23 05:45:00

Nykode Therapeutics announced that it has entered into a license and collaboration agreement with Regeneron for the discovery, development and commercialization of potential new vaccines for cancer and infectious diseases. The agreement includes five distinct programs, three within cancer and two within infectious diseases. Each of these may include several vaccine candidates, all of which being eligible for milestone and royalty payments. The vaccines will combine Regeneron’s unique antigen selection expertise and innovative VelociSuite in vivo models with Nykode Therapeutics’ modular vaccine platform and expertise in vaccine design. Nykode Therapeutics will be responsible for vaccine generation and characterization, as well as product supply through the end of Phase 1 trials. Regeneron willbe responsible for antigen identification, preclinical and clinical development, manufacturing and commercialization. Additionally, Nykode Therapeutics will potentially be eligible to receive more than USD 875 million in milestone payments, plus high single-digit to low double-digit tiered royalties on sales of commercialized products arisingfrom the collaboration, bringing the total potential value of the agreement to more than USD 925 million, plus royalties. Regeneron will cover costs for research, as well as potential clinical, regulatory, manufacturing and commercialization activities.

Vaccibody AS announced that it expects to receive NOK 178.305538 million in funding from Regeneron Pharmaceuticals, Inc.

2021-11-23 00:00:00

Vaccibody AS announced a private placement of 2,255,034 shares at a price of NOK 79.07 per share for the gross proceeds of NOK 178,305,538.38 on November 23, 2021. The transaction will include participation from Regeneron Pharmaceuticals, Inc.

Decibel Therapeutics, Inc. Announces Extension of Research Term Under Strategic Collaboration with Regeneron to Discover and Develop Gene Therapies for Hearing Loss

2021-11-22 12:30:00

Decibel Therapeutics announced that Regeneron has extended the research term of its collaboration with the Company to discover and develop gene therapies for hearing loss. The research term will be extended to November 15, 2023, and Regeneron will pay Decibel an extension fee of $10 million in Fourth Quarter of 2022. Under the collaboration launched in 2017, Decibel is developing three gene therapy programs targeting congenital, monogenic hearing loss with Regeneron. Decibel plans to initiate in 2022 a Phase 1/2 clinical trial of DB-OTO, the Company’s lead gene therapy product candidate, designed to provide hearing to individuals born with profound hearing loss due to mutation of the otoferlin gene. Decibel is also advancing AAV.103 and AAV.104, gene therapy programs targeting other monogenic forms of hearing loss, with Regeneron. AAV.103 aims to restore hearing in individuals with mutations in the GJB2 gene, and AAV.104 aims to restore hearing in individuals with mutations in the STRC gene. Through the collaboration, Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel's goal of discovering new medicines for congenital, monogenic hearing loss. Regeneron also directly participates in and provides financial support for Decibel's research and development efforts under the collaboration through milestone payments and reimbursement intended to fund approximately half of the costs of the collaboration programs. Decibel retains worldwide development and commercialization rights to the product candidates being developed in the collaboration and will pay Regeneron tiered royalties based on net sales.

Regeneron Pharmaceuticals, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov-30-2021 09:15 AM

2021-11-16 21:15:00

Regeneron Pharmaceuticals, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov-30-2021 09:15 AM.

Regeneron Pharmaceuticals, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Dec-01-2021 08:00 AM

2021-11-16 21:15:00

Regeneron Pharmaceuticals, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Dec-01-2021 08:00 AM. Venue: New York, New York, United States. Speakers: Robert E. Landry, Executive VP of Finance & CFO.

Regeneron Pharmaceuticals, Inc. Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021

2021-11-16 11:51:00

Regeneron Pharmaceuticals, Inc. Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021 . Speakers: Arsalan Shabbir, Senior Medical Director, Immunology & Inflammation Clinical Development.

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021

2021-11-15 12:30:00

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021.

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) announces an Equity Buyback for $3,000 million worth of its shares.

2021-11-12 21:11:00

Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) announces a share repurchase program. Under the program, the company will repurchase up to $3,000 million worth of its outstanding common stock.

Regeneron Pharmaceuticals, Inc. authorizes a Buyback Plan.

2021-11-12 00:00:00

The Board of Directors of Regeneron Pharmaceuticals, Inc. has authorized a buyback plan on November 12, 2021.

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use Recommends Approval of Regeneron Antibody Cocktail to Treat and Prevent COVID-19

2021-11-11 16:03:00

Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV® in the U.S. and Ronapreve™ in the European Union (EU) and other countries. The positive opinion is for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. A final decision from the European Commission regarding the approval of the antibody cocktail is expected in the near future. The positive opinion is based on two positive Phase 3 trials involving more than 6,000 individuals that evaluated the efficacy and safety of the antibody cocktail to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts). Regeneron invented the antibody cocktail and is collaborating with Roche, who is primarily responsible for development and distribution outside the U.S. In addition to this Marketing Authorization Application, the companies intend to submit a future Type II Variation to the EMA that seeks to expand the potential indication to include the treatment of patients hospitalized because of COVID-19. In October, the U.S. Food and Drug Administration (FDA) accepted for priority review the first of two Biologics License Applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year. In the U.S., REGEN-COV has not been approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) for use in certain?post-exposure prophylaxis?settings and as a treatment for non-hospitalized people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.

Regeneron Pharmaceuticals, Inc. Presents at Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov-11-2021 11:30 AM

2021-11-09 00:00:00

Regeneron Pharmaceuticals, Inc. Presents at Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov-11-2021 11:30 AM. Venue: Walter E. Washington Convention Center, District Of Columbia, Washington, United States. Speakers: Dimitris Skokos.

Regeneron Pharmaceuticals, Inc. Announces New Phase 3 Analyses Shows Single Dose of Regen-Cov® (Casirivimab and Imdevimab) Provides Long-Term Protection Against Covid-19

2021-11-08 12:00:00

Regeneron Pharmaceuticals, Inc. announced additional positive results from a Phase 3 trial jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), which assessed use of a single dose of investigational REGEN-COV® (1,200 mg administered via 4 subcutaneous injections) to prevent COVID-19 in uninfected individuals. The new analyses show REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration, which was previously reported in The New England Journal of Medicine. In results previously published, the trial met its primary endpoint, reducing the risk of COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.4% within 1 month of receiving REGEN-COV (p<0.0001). The new results released describe a pre-specified analysis for the following 7 months, throughout which an additional 45 symptomatic infections occurred. During this time period, REGEN-COV continued to prevent infection, without requiring additional doses. Compared to placebo (n=842), people who received a single dose of REGEN-COV (n=841) experienced: 81.6% reduced risk of developing COVID-19 during the pre-specified follow-up period, between months 2-8 (7 REGEN-COV, 38 placebo; 95% confidence interval [CI]: 59.8%, 91.6%; nominal p<0.0001). 81.5% reduced risk of developing COVID-19 at any time during the 8 months after receiving REGEN-COV (20 REGEN-COV, 108 placebo; 95% CI: 70.6%,88.4%; nominal p<0.0001). During the 8-month assessment period, 0 individuals in the REGEN-COV group were hospitalized due to COVID-19, compared to 6 individuals in the placebo group (1 person in the first month; 5 people during months 2-8). There were no deaths due to COVID-19 in any treatment group during the 8-month assessment period, and there were no new safety signals identified for REGEN-COV. The trial, which was fully enrolled in early 2021, allowed participants to become vaccinated if they wished once the primary efficacy treatment period (month 1) was complete. Vaccination rates during the months 2-8 assessment period were balanced, with 34.5% (n=290) of the REGEN-COV group and 35.2% (n=296) of the placebo group receiving at least 1 COVID-19 vaccine dose by the end of the 8-month assessment period.

Tranche Update on Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN)'s Equity Buyback Plan announced on February 5, 2021.

2021-11-04 07:20:00

From July 1, 2021 to September 30, 2021, the company has repurchased 304,588 shares, representing 0.29% for $190.57 million. With this, the company has completed the repurchase of 1,576,731 shares, representing 1.52% for $802.7 million under the buyback announced on February 5, 2021.

Regeneron Pharmaceuticals, Inc. has filed a Shelf Registration.

2021-11-04 00:00:00

Regeneron Pharmaceuticals, Inc. has filed a Shelf Registration. Security Name: Common Stock Security Name: Preferred Stock Security Name: Debt Securities Security Name: Warrants Transaction Features: Omnibus/Universal Shelf Registration

Regeneron Pharmaceuticals, Inc. Presents at 5th Annual NASH Summit, Dec-01-2021 02:30 PM

2021-11-03 08:15:00

Regeneron Pharmaceuticals, Inc. Presents at 5th Annual NASH Summit, Dec-01-2021 02:30 PM. Speakers: Roberto Calle, Executive Medical Director.

Hanson Wade Limited, 5th Annual NASH Summit, Nov 29, 2021 through Dec 02, 2021

2021-11-03 06:30:00

Hanson Wade Limited, 5th Annual NASH Summit, Nov 29, 2021 through Dec 02, 2021.

Second Dupixent® (dupilumab) Phase 3 Eosinophilic Esophagitis Trial to Demonstrate Significant Disease Improvements, Underscoring Role of Type 2 Inflammation in This Complex Disease

2021-10-25 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced results from a second Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. In September 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. At times, swallowing the smallest quantity of food or taking a sip of water can be a painful and worrisome choking experience. Those with EoE live with anxiety and frustration from having a constantly evolving list of trigger foods to avoid. Dilation (physical expansion) of the esophagus, which is used to address narrowing, is often painful. In severe cases, a feeding tube is the only option to ensure proper caloric intake and weight gain. People with EoE may have poor quality of life and are more likely to experience depression, especially as they age, than people without EoE. In the U.S. there are approximately 160,000 patients with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments. In this trial, 80 patients were enrolled into a Dupixent 300 mg weekly treatment group and 79 patients were enrolled into the placebo group. The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving peak esophageal intraepithelial eosinophil count of =6 eos/high power field [hpf]). Patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo: 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008). Dupixent patients experienced a 23.78 point improvement on the 0-84 DSQ scale, compared to a 13.86 point improvement for placebo (p<0.0001); baseline DSQ scores were approximately 38 and 36 points, respectively. Nearly 10 times as many Dupixent patients achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of placebo patients (p<0.0001). This was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of =6 eos/hpf; mean baseline peak levels were 89 and 84 eos/hpf, respectively. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, overall rates of adverse events were 84% (67/80) for Dupixent 300 mg weekly and 71% (55/78) for placebo. Adverse events that were more commonly (=5%) observed with Dupixent every week included injection site reactions (38% [30/80] Dupixent, 33% [26/78] placebo), fever (6% [5/80] Dupixent, 1% [1/78] placebo), sinusitis (5% [4/80] Dupixent, 0% [0/78] placebo), COVID-19 (5% [4/80] Dupixent, 0% [0/78] placebo) and hypertension (5% [4/80] Dupixent, 1% [1/78] placebo). No imbalance was observed in rates of treatment discontinuation due to adverse events between Dupixent (3% [2/80]) and placebo (3% [2/78]) groups prior to week 24.

Regeneron Pharmaceuticals, Inc. and Sanofi Announces Positive Pivotal Phase 3 Results from A Trial Evaluating Dupixent

2021-10-22 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced positive pivotal Phase 3 results from a trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions. The trial met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch. People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. It is often described as painful with burning, stinging and tingling of the skin. The debilitating signs and symptoms of prurigo nodularis can negatively impact health-related quality of life, including mental health, activities of daily living and social interactions. There are no approved systemic treatments for prurigo nodularis. High-potency topical steroids are commonly used, which are associated with safety risks if used long-term. In the Phase 3 PRIME2 trial, topline results comparing Dupixent (n=78) to placebo (n=82) showed: 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint; At week 24, nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline: 58% of Dupixent patients compared to 20% of placebo patients (p<0.0001); At week 24, nearly three times as many Dupixent patients achieved clear or almost clear skin: 45% of Dupixent patients compared to 16% of placebo patients (p<0.0001); Dupixent patients experienced significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The occurrences of treatment-emergent adverse events were generally similar between Dupixent and placebo groups (57% [44/77] Dupixent, 51% [42/82] placebo). Rates of conjunctivitis (6% [5/77] Dupixent, 0% [0/82] placebo) and herpes viral infections (6% [5/77] Dupixent, 0% [0/82] placebo) were similar to what was previously observed in atopic dermatitis trials, and there was a numerically lower rate of skin infections observed with Dupixent (5% [4/77] Dupixent, 9% [7/82] placebo). Additionally, 3% (2/77) of Dupixent patients and 30% (25/82) of placebo patients discontinued prior to week 24.

Regeneron Pharmaceuticals, Inc. Presents at HLTH 2021 Conference, Oct-17-2021 through Oct-20-2021

2021-10-14 16:17:00

Regeneron Pharmaceuticals, Inc. Presents at HLTH 2021 Conference, Oct-17-2021 through Oct-20-2021. Venue: Boston, Massachusetts, United States. Presentation Date & Speakers: Oct-19-2021, Aris Baras, Senior Vice President of Regeneron Genetics Center, George D. Yancopoulos, Scientific Founder, President, Chief Scientific Officer & Director.

Regeneron Pharmaceuticals, Inc. to Report Q3, 2021 Results on Nov 04, 2021

2021-10-11 20:15:00

Regeneron Pharmaceuticals, Inc. announced that they will report Q3, 2021 results Pre-Market on Nov 04, 2021

Regeneron Pharmaceuticals, Inc., Q3 2021 Earnings Call, Nov 04, 2021

2021-10-11 20:15:00

Regeneron Pharmaceuticals, Inc., Q3 2021 Earnings Call, Nov 04, 2021

HLTH, LLC, HLTH 2021 Conference, Oct 17, 2021 through Oct 20, 2021

2021-10-08 12:30:00

HLTH, LLC, HLTH 2021 Conference, Oct 17, 2021 through Oct 20, 2021. Venue: Boston, Massachusetts, United States.

Regeneron Pharmaceuticals, Inc. Presents at Trade & Channel Strategies, Dec-13-2021 03:45 PM

2021-10-01 17:59:00

Regeneron Pharmaceuticals, Inc. Presents at Trade & Channel Strategies, Dec-13-2021 03:45 PM. Venue: Hilton at Penn’s Landing, Philadelphia, Pennsylvania, United States. Speakers: Rena Goins, Executive Director, Global Trade, GPO & Distribution.

Informa plc, Trade & Channel Strategies, Dec 13, 2021 through Dec 17, 2021

2021-10-01 17:42:00

Informa plc, Trade & Channel Strategies, Dec 13, 2021 through Dec 17, 2021. Venue: Hilton at Penn’s Landing, Philadelphia, Pennsylvania, United States.

Regeneron Pharmaceuticals, Inc. Presents at Annual Ophthalmology Innovation Summit (OIS) Retina @ASRS Conference, Oct-07-2021 02:45 PM

2021-09-30 23:02:00

Regeneron Pharmaceuticals, Inc. Presents at Annual Ophthalmology Innovation Summit (OIS) Retina @ASRS Conference, Oct-07-2021 02:45 PM. Venue: San Antonio, Texas, United States. Speakers: David Scisciani, Director Strategic Accounts.

Healthegy, Inc., Annual Ophthalmology Innovation Summit (OIS) Retina @ASRS Conference, Oct 07, 2021

2021-09-30 20:05:00

Healthegy, Inc., Annual Ophthalmology Innovation Summit (OIS) Retina @ASRS Conference, Oct 07, 2021. Venue: San Antonio, Texas, United States.

Regeneron Pharmaceuticals, Inc. Announces a Trial Assessing Investigational REGEN-COV™ (casirivimab and imdevimab) in Patients Hospitalized with COVID-19 Met its Primary Endpoint

2021-09-30 05:00:00

Regeneron Pharmaceuticals, Inc. announced that a trial assessing investigational REGEN-COV™ (casirivimab and imdevimab) in patients hospitalized with COVID-19 met its primary endpoint. Trial results will be presented at IDWeek 2021, and show that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen (p=0.0172). The trial also had clinical results supportive of the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed. REGEN-COV is an investigational medicine authorized by the U.S. Food and Drug Administration (FDA) under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. In the U.S., it is not currently authorized in patients who are hospitalized due to COVID-19 infection. The trial, which was stopped due to slow enrollment after recruiting just over one third the patients originally planned, found that patients who received REGEN-COV (2,400 mg or 8,000 mg) in addition to standard-of-care (SOC) experienced numeric improvements across all clinical endpoints assessed, compared to SOC alone (placebo). Researchers did not observe any clinical difference between the two REGEN-COV doses (2,400 mg or 8,000 mg), or any serious or dose-dependent safety signals in REGEN-COV treated patients. In a safety analysis involving 2,007 patients (REGEN-COV=1,340, placebo=667) serious adverse events occurred in 21% REGEN-COV patients (n=285) and 26% placebo patients (n=174). Infusion-related reactions and hypersensitivity reactions that were grade =2 occurred more commonly among REGEN-COV patients (2% and 1% respectively) than placebo patients (1% and <0.5% respectively). The trial originally assessed a broader group of patients; however in late 2020 the trial was adjusted to exclude patients who were on mechanical ventilation or high-flow oxygen at baseline based on a potential safety signal identified by an Independent Data Monitoring Committee in 199 patients on mechanical ventilation or high flow-oxygen, a finding that was not replicated in the much larger RECOVERY trial that enrolled hospitalized patients with a broad range of severe COVID-19, including these patient groups. The robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention to hospitalization: Prevention of symptomatic infection in both uninfected and infected asymptomatic household contacts of SARS-CoV-2 infected individuals; Treatment of non-hospitalized patients already infected with SARS-CoV-2; and to Treatment of certain patients hospitalized due to COVID-19 infection (as detailed in the IDWeek presentation), including the RECOVERY trial. Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern circulating within the U.S., including Delta (first identified in India), Gamma (first identified in Brazil), Beta (first identified in South Africa) and Mu (first identified in Colombia), with information available in the Fact Sheet for Healthcare Providers. Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants. In the U.S., REGEN-COV is available for free to?eligible people, as part of a?U.S.?government funded program and earlier this month Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV. Information on how to access REGEN-COV throughout the U.S. is available from the Department of Health and Human Services and the National Infusion Center Association. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Regeneron Pharmaceuticals, Inc. Presents at Longwood Healthcare Leaders Conference, Oct-04-2021 through Oct-05-2021

2021-09-28 18:44:00

Regeneron Pharmaceuticals, Inc. Presents at Longwood Healthcare Leaders Conference, Oct-04-2021 through Oct-05-2021. Presentation Date & Speakers: Oct-04-2021, Nouhad Husseini, Senior Vice President of Business Development. Oct-05-2021, David Weinreich, Executive Vice President of Global Clinical Development, George D. Yancopoulos, Scientific Founder, President, Chief Scientific Officer & Director.

Regeneron Pharmaceuticals, Inc. Presents at Transparency & Aggregate Spend, Dec-06-2021 through Dec-10-2021

2021-09-28 14:33:00

Regeneron Pharmaceuticals, Inc. Presents at Transparency & Aggregate Spend, Dec-06-2021 through Dec-10-2021. Venue: Hilton Philadelphia at Penn's Landing, Philadelphia, Pennsylvania, United States. Presentation Date & Speakers: Dec-06-2021, Melissa Blaco, Senior Director, Compliance Reporting. Dec-10-2021, Melissa Blaco, Senior Director, Compliance Reporting.

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021

2021-09-28 13:09:00

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021.

U.S. Food and Drug Administration Accepts Biologics License Application of Regeneron Pharmaceuticals, Inc

2021-09-28 11:00:00

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The target action date for the FDA decision is January 30, 2022. The sBLA is also being reviewed under the FDA'sProject Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada and Switzerland. Additional global regulatory submissions are planned, including in the European Union (EU) by the end of 2021. The sBLA is supported by results from a Phase 3 trial that enrolled patients irrespective of PD-L1 expression status and is being conducted with The GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. It is estimated that approximately 570,000 people are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new cases diagnosed annually and approximately 4,000 die each year.

Informa plc, Transparency & Aggregate Spend, Dec 06, 2021 through Dec 10, 2021

2021-09-27 17:31:00

Informa plc, Transparency & Aggregate Spend, Dec 06, 2021 through Dec 10, 2021. Venue: Hilton Philadelphia at Penn's Landing, Philadelphia, Pennsylvania, United States.

Regeneron Pharmaceuticals, Inc. Presents at Festival of Biologics Basel 2021, Nov-09-2021

2021-09-22 15:38:00

Regeneron Pharmaceuticals, Inc. Presents at Festival of Biologics Basel 2021, Nov-09-2021 . Venue: Congress Centre, Basel, Switzerland. Speakers: David Di Lillo, Associate Director.

Regeneron Pharmaceuticals, Inc. and Sanofi Announce New Dupixent® (Dupilumab) Data in Patients as Young as Six Years Old with Moderate-To-Severe Atopic Dermatitis to Be Presented at WCPD and EADV

2021-09-21 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced that new Dupixent® (dupilumab) analyses in patients as young as six years old with moderate-to-severe atopic dermatitis will be presented at the 14th World Congress of Pediatric Dermatology Annual Congress (WCPD) from September 22-25 and the 30thEuropean Academy of Dermatology and Venereology Congress (EADV) from September 29, 2021-October 2, 2021. Notable Dupixent presentations include long-term efficacy and safety data showing the impact of Dupixent on signs and symptoms of moderate-to-severe atopic dermatitis in children, adolescents and adults. More than 30 presentations highlight Dupixent results on skin lesions, itch and skin infections, as well as sleep and health-related quality of life, for patients and their families, such as in adults with a history of mental health disorders and in children with anxiety and depression. Real-world evidence will also be presented from observational registries and claims databases across multiple geographies. Disease burden data to be presented at EADV include results from the Atopic Dermatitis Global Adolescent and Pediatric survey on how patients, caregivers and physicians view the full impact of moderate-to-severe atopic dermatitis, based on findings from more than 3,900 people across 13 countries. Data will also be shared from the Quality of Care in ADInitiative, which documents best practices from 32 atopic dermatitis centers across the world, focused on the value of patient education and communication. Data to be presented at WCPD 2021; Clinical Efficacy and Safety of Dupixent in Atopic Dermatitis. Oral presentation (September 24, 3:40-3:50 pm BST): #SP42 Long-Term Efficacy and Safety Data for Dupilumab in a Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in Patients Aged = 6 to < 12 Years With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD), Michael Cork. Poster #P22: Efficacy and Safety of Dupilumab for up to 1 Year in a Phase 3 Open-Label Extension (OLE) Trial (LIBERTY AD PED-OLE) in Adolescents With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD), Andrew Blauvelt Poster #P23: 52-Week Laboratory Safety Findings From an Open-Label Extension (OLE) Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael Cork. Poster #P33: Dupilumab Improved Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis: Analysis From the LIBERTY AD PEDS Trial, Gil Yosipovitch. Poster #P35: IGAxBSA: An Alternative to EASI in Assessing Disease Severity and Response in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis, Amy Paller. Poster #P36: Dupilumab Induces Rapid and Sustained Improvement in Clinical Signs in Children With Severe Atopic Dermatitis, Amy Paller. Poster #P38: Dupilumab Significantly Improves All POEM Components in Children Aged =6 to <12 Years With Severe Atopic Dermatitis, Andreas Wollenberg. Poster #P40: Efficacy and Safety of Dupilumab in Children Aged = 6 to < 18 Years With a History of Infection (LIBERTY AD PEDS, LIBERTY AD ADOL), Michael Cork. Poster #P41: Dupilumab in Children Aged =6 to <12 Years Promotes Rapid and Sustained Improvement in Clinical Signs of Atopic Dermatitis (LIBERTY AD PEDS), Amy Paller. Poster #P44: Dupilumab in Children Aged =6–<12 Years Significantly Improves Signs and Symptoms of Atopic Dermatitis Assessed by SCORAD, Sébastien Barbarot. Data to be presented at EADV 2021; Long-Term Efficacy and Safety of Dupixent in Atopic Dermatitis. Oral Presentation (September 30, 10:00-11:00 am CEST): #2008 Long-Term Efficacy of Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label Extension Trial up to 172 Weeks, Lisa Beck. Poster #P0258: Dupilumab Provides Long-Term Improvement in Pruritus in Children With Severe Atopic Dermatitis, and Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis, Amy Paller. Poster #P0723: Patient Well-Being and Perception of Treatment Effect With Long-Term Dupilumab Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis, Eric Simpson. Poster #P0726: Safety of Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label Extension Trial up to 172 Weeks, Andreas Wollenberg. Poster #P0727: Dupilumab Provides Long-Term Efficacy Over 2.5 Years in Adults With Moderate-to-Severe Atopic Dermatitis, Lisa Beck. Poster #P0729: Dupilumab Monotherapy Provides Long-Term Control and Prevents Flares in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16, Andreas Wollenberg. Quality of Life Data for Dupixent in Atopic Dermatitis. Poster #P0239: Dupilumab Improves Family Quality of Life in Children Aged 6-11 Years With Severe Atopic Dermatitis: An Analysis From the Phase 3 LIBERTY AD PEDS Trial, Amy Paller. Poster #P0252: Dupilumab Provides Long-Term Improvement of Sleep Loss in Children, Adolescents, and Adults With Atopic Dermatitis, Lisa Beck. Poster #P0722: Dupilumab Monotherapy Provides Long-Term Improvement in Quality of Life in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16, Carlos Ferrándiz. Additional Efficacy and Safety Analyses of Dupixent in Atopic Dermatitis. Poster #P0230: Dupilumab Treatment in Adult Patients Is Efficacious Regardless of Age at Atopic Dermatitis Onset, Jonathan Silverberg. Poster #P0231: Dupilumab in Children Aged = 6 to < 12 Years Promotes Rapid Improvement in Clinical Signs of Atopic Dermatitis, Amy Paller. Poster #P0251: Infections in Dupilumab Pediatric Clinical Trials in Atopic Dermatitis — A Pooled Analysis, Amy Paller. Poster #P0255: Dupilumab Significantly Improves Treatment Response in Children With Severe Atopic Dermatitis From the Patient's Perspective and by Clinical Assessments of Signs, Symptoms, and Quality of Life: Results From the LIBERTY AD PEDS Phase 3 Clinical Trial, Stephan Weidinger. Poster #P0256: Dupilumab Treatment Is Efficacious in Adult Atopic Dermatitis Patients Independent of History of Mental Health Disorders: A Post Hoc Analysis of Pooled Phase 3 Trials, Jonathan Silverberg. Poster #P0260: Dupilumab Treatment Is Efficacious in Adult Atopic Dermatitis Patients Regardless of History of Infection: A Pooled Analysis of Four Phase 3 Trials, Andreas Wollenberg Poster #P0733: Dupilumab Monotherapy Provides 1 Year Sustained Response in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16, With No Need of Concomitant Topical Steroids, Margitta Worm. Real-World Analyses. Poster #P0257: Improvement in Disease Severity and Quality of Life in Patients With Atopic Dermatitis Treated With Dupilumab for up to 18 Months: Real-World Data From the PROSE Registry, Jerry Bagel. Poster #P0259: Use of Systemic Therapies in Adults With Atopic Dermatitis: 18-Month Results From the European Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (EUROSTAD), Marjolein De Bruin-Weller.

Sanofi and Regeneron Pharmaceuticals, Inc. Present Positive Phase 3 Results for Libtayo (Cemiplimab) and Chemotherapy First-Line Treatment Combination Significantly Improved Overall Survival in Patients with Advanced NSCLC At the European Society for Medical Oncology Virtual Congress 2021

2021-09-19 15:30:00

Positive Phase 3 results for Sanofi and Regeneron Pharmaceuticals, Inc.’s Libtayo® (cemiplimab) combination treatment were presented during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of PD-1 inhibitor Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) irrespective of histology and across all PD-L1 expression levels, compared to chemotherapy alone. These results were also achieved in a patient population with varied baseline characteristics and will form the basis of regulatory submissions, including in the U.S. and European Union (EU). In the overall population, patients treated with the Libtayo combination (n=312) experienced significant improvements compared to those receiving chemotherapy alone (n=154), including a: 22-month median OS compared to 13 months for chemotherapy, representing a 29% relative reduction in the risk of death (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93; p=0.014). The 12-month probability of survival was 66% for the Libtayo combination and 56% for chemotherapy. 8-month median progression-free survival (PFS) compared to 5 months for chemotherapy, representing a 46% relative reduction in the risk of disease progression (HR: 0.56; 95% CI: 0.44 to 0.70; p<0.0001). The 12-month probability of PFS was 38% for the Libtayo combination and 16% for chemotherapy. 43% objective response rate (ORR) compared to 23% for chemotherapy. 16-month median duration of response (DOR) compared to 7 months for chemotherapy. Favorable patient-reported outcomes were also observed. Specifically, the Libtayo combination delayed deterioration in pain symptoms (HR: 0.39; 95% CI: 0.26 to 0.60; nominal p<0.0001) and showed a trend towards delayed deterioration in global health status/quality of life (HR: 0.78; 95% CI: 0.51 to 1.19; nominal p=0.248), compared to chemotherapy. The Libtayo combination also improved pain symptoms, compared to chemotherapy (-4.98 difference in baseline changes between treatment groups; 95% CI: -8.36 to -1.60; nominal p=0.004). No new Libtayo safety signals were identified. The median duration of exposure was 38 weeks for the Libtayo combination (n=312) and 21 weeks for chemotherapy (n=153). Adverse events (AEs) of any grade occurred in 96% of patients receiving the Libtayo combination and 94% of patients receiving chemotherapy alone, with 19% and 0% being immune-mediated, respectively. For the Libtayo combination and chemotherapy groups, the most common AEs were anemia (44%, 40%), alopecia (37%, 43%) and nausea (25%, 16%); grade =3 AEs occurring in =5% of patients were anemia (10%, 7%) and neutropenia (both 6%). Treatment discontinuation due to AEs occurred in 5% of patients receiving the Libtayo combination and 3% receiving chemotherapy. Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with =50% PD-L1 expression, approximately 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting. The use of Libtayo in combination with chemotherapy for advanced NSCLC is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Regeneron Pharmaceuticals, Inc. Enters into Supply Agreement with Army Contracting Command, New Jersey

2021-09-16 20:02:00

On September 14, 2021, Regeneron Pharmaceuticals, Inc. (“ Regeneron” or the “ Company”) entered into a modified Statement of Work (the “ Amendment”) under the supply agreement (the “ Supply Agreement”) with the Army Contracting Command, New Jersey, an entity acting on behalf of the U.S. Department of Defense and the U.S. Department of Health and Human Services (collectively, the “ U.S. Government”), to supply to the U.S. Government an additional 1.4 million doses of REGEN-COVTM (casirivimab and imdevimab), the Company’s cocktail of two monoclonal antibodies that has received an Emergency Use Authorization from the U.S. Food and Drug Administration (the “ FDA”) for use in certain individuals in the United States. Pursuant to the Supply Agreement, as amended by the Amendment (the “ Amended Supply Agreement”), the U.S. Government is obligated to purchase all such filled and finished doses of drug product delivered to vendor-managed inventory by January 31, 2022. Regeneron is required to deliver at least 100,000 doses by the end of each of September, October, November, and December 2021, with the remaining doses to be delivered by January 31, 2022, and to use commercially reasonable efforts to deliver doses early. In addition, the Amendment sets forth a good faith obligation to deliver filled and finished doses of drug product based on a non-binding monthly schedule that, if met, would result in the delivery of all doses by the end of 2021. The U.S. Government will acquire doses at the lowest therapeutic dose (other than a pediatric dose) authorized or approved by the FDA prior to or on the date of delivery for a price of $2,100 per dose, resulting in payments to Regeneron of $2.940 billion in the aggregate based on the delivery of 1.4 million doses, and will be obligated to pay for partial deliveries. A number of factors may impact available filled and finished supply, including manufacturing considerations. The Company is also obligated to distribute the filled and finished drug product to patient care sites as directed by the U.S. Government. The Amended Supply Agreement contains terms and conditions that are customary for U.S. Government agreements of this nature, including provisions giving the U.S. Government the right to terminate the Amended Supply Agreement for convenience. If the Amended Supply Agreement is terminated for convenience prior to completion, Regeneron is entitled to be paid certain termination costs, including the percentage of the contract price reflecting the percentage of work performed plus certain reasonable charges resulting from termination.

Regeneron Pharmaceuticals, Inc. Presents at Indegene Digital Summit, Sep-24-2021 01:00 PM

2021-09-16 17:31:00

Regeneron Pharmaceuticals, Inc. Presents at Indegene Digital Summit, Sep-24-2021 01:00 PM. Speakers: Arvind Balasundaram, Executive Director, Commercial Insights & Analytics.

Regeneron Pharmaceuticals, Inc. - Special Call

2021-09-15 15:27:00

To share updates on company's oncology portfolio

Indegene, Inc., Indegene Digital Summit, Sep 23, 2021 through Sep 24, 2021

2021-09-15 12:30:00

Indegene, Inc., Indegene Digital Summit, Sep 23, 2021 through Sep 24, 2021.

Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of Regen-Cov™ Antibody Cocktail

2021-09-14 21:33:00

Regeneron Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services and the Department of Defense will purchase 1.4 million additional doses of REGEN-COV. The government will continue to provide REGEN-COV at no cost to patients. Under the new agreement, Regeneron will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022, at a cost of $2,100 per dose. This new agreement follows two earlier agreements with the U.S. government announced in July 2020 and January 2021. REGEN-COV is an investigational medicine authorized by the U.S. Food and Drug Administration under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. In addition, the robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention to hospitalization: Prevention of symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals. Treatment of non-hospitalized patients already infected with SARS-CoV-2. Treatment of certain patients hospitalized due to COVID-19 infection, including the UKRECOVERY trial. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS's Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Regeneron Pharmaceuticals, Inc. Presents at 8th Annual Mobile in Clinical Trials Conference, Sep-27-2021

2021-09-09 20:44:00

Regeneron Pharmaceuticals, Inc. Presents at 8th Annual Mobile in Clinical Trials Conference, Sep-27-2021 . Speakers: Rinol Alaj, Director, Head of COA and Patient Innovation.

The Conference Forum, 8th Annual Mobile in Clinical Trials Conference, Sep 27, 2021

2021-09-09 11:30:00

The Conference Forum, 8th Annual Mobile in Clinical Trials Conference, Sep 27, 2021.

Regeneron Pharmaceuticals, Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021

2021-09-08 22:27:00

Regeneron Pharmaceuticals, Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021 . Speakers: Hanne Bak, Senior Vice President of Preclinical Manufacturing & Process Development.

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021

2021-09-08 21:27:00

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021.

Regeneron Pharmaceuticals, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 08:45 AM

2021-09-08 20:23:00

Regeneron Pharmaceuticals, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 08:45 AM. Venue: New Windsor, United States.

Regeneron Pharmaceuticals, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 09:20 AM

2021-09-08 20:23:00

Regeneron Pharmaceuticals, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 09:20 AM. Venue: New York, United States.

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022

2021-09-04 12:00:00

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022. Venue: Orlanda, Florida, United States.

LSX Ltd, 4th Longevity Leaders World Congress, Apr 26, 2022 through Apr 27, 2022

2021-09-04 07:34:00

LSX Ltd, 4th Longevity Leaders World Congress, Apr 26, 2022 through Apr 27, 2022. Venue: etc. venues, 133 Houndsditch, Liverpool Street, London, United Kingdom.

LSX Ltd, 5th LSX USA Congress & CEO Forums, Jun 21, 2022 through Jun 22, 2022

2021-09-04 07:34:00

LSX Ltd, 5th LSX USA Congress & CEO Forums, Jun 21, 2022 through Jun 22, 2022. Venue: Boston, United States.

Regeneron Pharmaceuticals, Inc. and Sanofi Announce Positive Pivotal Phase 3 Results from Trial Evaluating Dupixent (Dupilumab) to Treat Moderate-To-Severe Atopic Dermatitis in Children Aged 6 Months to 5 Years

2021-08-30 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced positive pivotal Phase 3 results from a trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in children aged 6 months to 5 years. The trial met its primary and all secondary endpoints, showing that Dupixent added to standard-of-care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone (placebo). Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis. The data reinforce the well-established efficacy and safety profile of Dupixent in other age groups, including a lower observed rate of skin infections in the Dupixent group compared to placebo. During the 16-week treatment period, Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo). These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents and adults to date. Atopic dermatitis is a chronic type 2 inflammatory skin disease, with the age of onset younger than 5 years in 85 to 90% of patients. The debilitating symptoms that infants and young children with moderate-to-severe atopic dermatitis experience often continue through adulthood and include intense, persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, and crusting and oozing, along with increased risk of skin infections. Moderate-to-severe atopic dermatitis significantly impacts the life of a young child, their parents and caregivers, including their mood, sleep patterns, and quality of life. In addition, the underlying type 2 inflammation involved in atopic dermatitis can contribute to the development of other atopic diseases, like asthma and certain allergies, that may also appear throughout a person's life. Patients received Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus TCS or placebo. The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75). The pre-specified primary analysis showed that at 16 weeks, among patients treated with Dupixent: 28% achieved clear or almost-clear skin compared to 4% with placebo (p<0.0001), the primary endpoint. 53% achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo (p<0.0001), the co-primary endpoint outside of the U.S. 70% average improvement from baseline in overall disease severity (EASI) compared to 20% improvement with placebo (p<0.0001). 49% average improvement from baseline in itch compared to 2% improvement with placebo (p<0.0001). Significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. For the 16-week treatment period, overall rates of adverse events (AEs) were 64% for Dupixent and 74% for placebo. Most common AEs and AEs of special interest included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo) and injection site reactions (2% Dupixent, 3% placebo). Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It was invented using Regeneron's proprietary VelocImmune® technology. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). The efficacy and safety of Dupixent in children below the age of 6 years have not been fully evaluated by any regulatory authority.

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.

Regeneron Pharmaceuticals, Inc. Announces Encouraging Topline Phase 2 Data of High-Dose Aflibercept in Wet Age-Related Macular Degeneration

2021-08-24 11:00:00

Regeneron Pharmaceuticals, Inc. announced that an ongoing Phase 2 proof-of-concept trial evaluating an investigational 8 mg dose of aflibercept met its primary safety endpoint, with no new safety signals observed compared to the currently-approved 2 mg dose of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). In this small trial involving 106 patients, a higher proportion of patients in the aflibercept 8 mg group had no retinal fluid (43.4%, n=23/53) compared to patients treated with EYLEA 2 mg (26.4%, n=14/53) (p=0.067) at week 16, the primary efficacy endpoint. At this timepoint patients had received three initial doses (administered at weeks 0, 4 and 8), after which dosing was extended. Aflibercept 8 mg is currently being evaluated in two large Phase 3 trials in wet AMD and diabetic macular edema (DME), which are expected to report results in the second half of 2022. The trials will assess the safety and efficacy of aflibercept 8 mg for up to two years, with visual acuity as the primary efficacy endpoint at 48 weeks, measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA). Both trials will assess aflibercept 8 mg compared to EYLEA 2 mg, testing dosing intervals of every 12 weeks and every 16 weeks. During the initial 16 weeks of the Phase 2 trial, adverse events (AEs) in the study eye occurred in 17.0% (9 of 53) of aflibercept 8 mg patients and 22.6% (12 of 53) of EYLEA 2 mg patients. Serious ocular AEs occurred in two patients overall, one in the aflibercept 8 mg group (retinal tear) and one in the EYLEA 2 mg group (visual acuity reduced). There were no AEs of intraocular inflammation (including occlusive retinal vasculitis), anti-platelet trialists' collaboration (APTC)-defined arterial thromboembolic events or deaths in either patient group. Wet AMD is the leading cause of vision loss among people 50 years and older in the U.S. Existing anti-VEGF treatments including EYLEA have helped change the course of disease for millions of patients worldwide, and efforts to develop new medicines are focused on further enhancing clinical effectiveness while extending the time between treatment doses. This new, concentrated high-dose aflibercept formulation enables a greater amount of medicine to be administered with each treatment, potentially extending the time between doses while retaining the efficacy and safety profile seen with EYLEA 2 mg. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer.

Society for Immunotherapy of Cancer, Inc., Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov 10, 2021 through Nov 14, 2021

2021-08-17 11:12:00

Society for Immunotherapy of Cancer, Inc., Society for Immunotherapy of Cancer's 36th Annual Meeting, Nov 10, 2021 through Nov 14, 2021. Venue: Walter E. Washington Convention Center, District Of Columbia, Washington, United States.

Ocular Therapeutix Announces Termination of the Collaboration with Regeneron to Develop a Sustained-Release Formulation of Aflibercept for the Treatment of Wet AMD and other Serious Retinal Diseases

2021-08-05 20:01:00

Ocular Therapeutix, Inc. announced that Regeneron has terminated the option and license agreement collaboration between the companies. The termination became effective August 5, 2021. The collaboration with Regeneron was initially formed in 2016 for the development and commercialization of products containing the Company’s sustained-release hydrogel technology in combination with Regeneron’s large molecule vascular endothelial growth factor (“VEGF”)-targeting compounds to address conditions of the eye. Under a 2020 amendment, the Company and Regeneron’s efforts have focused on research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space for the treatment of retinal diseases.

Phase 3 Trial of Sanofi and Regeneron’s PD-1 Inhibitor Libtayo® (Cemiplimab) Combined with Chemotherapy Stopped Early Due to Significant Improvement in Overall Survival in Patients with First-Line Advanced Non-Small Cell Lung Cancer

2021-08-05 10:00:00

The Phase 3 trial of Sanofi and Regeneron’s PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC). Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. These data are planned to form the basis of regulatory submissions in the U.S. and European Union. The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. In this top-line initial analysis of 466 patients, combining Libtayo with chemotherapy reduced the risk of death by 29% compared to chemotherapy alone (hazard ratio: 0.71; 95% confidence interval [CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16 months to not evaluable) for Libtayo and chemotherapy, and 13 months (95% CI: 12 to 16 months) for chemotherapy alone. No new Libtayo safety signals were identified in the IDMC analysis, and additional detailed efficacy and safety data will be presented at an upcoming medical meeting. Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with =50% PD-L1 expression, approximately 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting. The use of Libtayo in combination with chemotherapy for advanced NSCLC is currently under clinical investigation, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Tranche Update on Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN)'s Equity Buyback Plan announced on February 5, 2021.

2021-08-05 07:11:00

From April 1, 2021 to June 30, 2021, the company has repurchased 581,878 shares, representing 0.56% for $288.66 million. With this, the company has completed the repurchase of 1,272,143 shares, representing 1.23% for $612.13 million under the buyback announced on February 5, 2021.

Regeneron Pharmaceuticals, Inc. Announces That the New England Journal of Medicine Published Positive Detailed Results from Phase 3 Trial That Assessed the Ability of REGEN-COV™

2021-08-04 21:05:00

Regeneron Pharmaceuticals, Inc. announced that the New England Journal of Medicine (NEJM) published positive detailed results from a Phase 3 trial that assessed the ability of REGEN-COV™ (casirivimab and imdevimab) to prevent COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial met its primary endpoint, reducing the risk of symptomatic infections by 81% (p<0.001), with a 93% reduction of symptomatic infections after the first week, and no dose-limiting toxicities observed. Regeneron previously announced initial results from the Phase 3 trial, which was jointly run with the COVID-19 Prevention Trials Network (CoVPN) National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention to hospitalization: Prevention of symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected contacts as detailed in today's publication, and infected contacts); Treatment of non-hospitalized patients already infected with SARS-CoV-2; Treatment of certain patients hospitalized due to COVID-19 infection, including the RECOVERY trial. In the U.S., REGEN-COV is currently authorized to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19 or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. REGEN-COV has not been approved by the Food and Drug Administration (FDA), but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. REGEN-COV use is increasing across the U.S. following the latest surge, with recent weekly orders surpassing 50,000 doses. In addition to the increasing proportion of patients who now receive REGEN-COV, Regeneron continues to work to ensure all healthcare providers and people who may benefit from this important therapy are aware of its availability. Multiple analyses, including a recent publication in Cell, have shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil) and Beta (B.1.351; first identified in South Africa). Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C. Regeneron is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

American Society Of Hematology, 63rd American Society of Hematologists Annual Meeting & Exposition, Dec 11, 2021 through Dec 15, 2021

2021-07-31 11:04:00

American Society Of Hematology, 63rd American Society of Hematologists Annual Meeting & Exposition, Dec 11, 2021 through Dec 15, 2021. Venue: Georgia World Congress Center, Atlanta, Georgia, United States.

Fda Expands Authorized Use of Regen-Cov™ (Casirivimab and Imdevimab)

2021-07-30 17:45:00

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab). The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons). In those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly. This new indication in people aged 12 and older is in addition to the previously granted authorization to treat non hospitalized patients. REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19. Under the EUA for post-exposure prophylaxis, REGEN-COV can be administered by subcutaneous injection or intravenous infusion. For people who aren't expected to mount an adequate immune response to vaccination and who have an ongoing exposure to SARS-CoV-2 for more than four weeks, the initial 1,200 mg dose can be followed by subsequent repeat dosing of REGEN-COV 600 mg once every four weeks, for the duration of ongoing exposure. REGEN-COV has not been approved by the FDA, but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Multiple analyses, including a recent publication in Cell, have shown that REGEN-COV retains potency against the main variants of concern circulating within the U.S., including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil) and Beta (B.1.351; first identified in South Africa). Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. Regeneron is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

Regeneron Pharmaceuticals, Inc. and Sanofi Announces Pivotal Phase 3 Trial Evaluating Dupixent® (Dupilumab) in Patients with Moderate-To-Severe Chronic Spontaneous Urticaria

2021-07-29 04:59:00

Regeneron Pharmaceuticals, Inc. and Sanofi announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program. CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, and can also affect the throat and upper airways. CSU is typically treated with antihistamines but the disease remains uncontrolled for up to 50% of patients who have limited available treatment options. CSU is the fifth disease for which Dupixent has positive Phase 3 data including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational). In the trial (n=138), adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. Patients experienced a: 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the U.S. (secondary endpoint in the EU). 65% reduction in urticaria activity (itch and hive) severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with Dupixent versus 12.00 point reduction with placebo, p<0.001), the primary endpoint in EU (secondary endpoint in the U.S.). The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups (50% Dupixent, 59% placebo). The most common adverse events were injection site reactions (11% Dupixent, 13% placebo). The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

Regeneron and AstraZeneca to Research, Develop and Commercialize New Small Molecule Medicines for Obesity

2021-07-27 11:00:00

Regeneron Pharmaceuticals, Inc. and AstraZeneca announced that the companies have entered into a collaboration to research develop and commercialize small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The collaboration builds on the recent discovery from the Regeneron Genetics Center with the potential to treat obesity and related co-morbidities. The collaboration builds on the recent discovery from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated soon after discovery of the target so that potential treatments can be developed as quickly as possible. The companies will evenly split research and development costs and share equally in any future potential profits.

Regeneron Pharmaceuticals, Inc. Announces Japan Becomes First Country to Approve Regeneron Antibody Cocktail (Casirivimab and Imdevimab) for the Treatment of Mild to Moderate Covid-19

2021-07-20 05:00:00

Regeneron Pharmaceuticals, Inc. announced that Japan'sMinistry of Health, Labour and Welfare (MHLW) has approved Regeneron's casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. This marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve™ in other countries, has received a full approval to treat COVID-19. Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada. In Japan, the antibody cocktail was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The approval was based on results from a Phase 3 trial in high-risk non-hospitalized patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70%, as well as results from a Phase 1 trial that examined the safety, tolerability and pharmacokinetics in Japanese people. Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. In December 2020, Chugai obtained development and exclusive commercialization rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Regeneron Pharmaceuticals, Inc. Presents at 2021 FDA/PDA Joint Regulatory Conference, Sep-27-2021

2021-07-15 14:25:00

Regeneron Pharmaceuticals, Inc. Presents at 2021 FDA/PDA Joint Regulatory Conference, Sep-27-2021 . Speakers: Gang Chen.

Parenteral Drug Association, U.S. Food and Drug Administration, 2021 FDA/PDA Joint Regulatory Conference, Sep 27, 2021 through Sep 29, 2021

2021-07-15 13:17:00

Parenteral Drug Association, U.S. Food and Drug Administration, 2021 FDA/PDA Joint Regulatory Conference, Sep 27, 2021 through Sep 29, 2021.

ISA Pharmaceuticals B.V. announced that it has received €26 million in funding from Invest-NL, Regeneron Pharmaceuticals, Inc. and other investors

2021-07-13 00:00:00

ISA Pharmaceuticals B.V. announced that it has received €26 million in a round of funding on July 13, 2021. The transaction included participation from new investor Invest-NL, existing investor Regeneron Pharmaceuticals, Inc. and other investors.

Regeneron Pharmaceuticals, Inc. to Report Q2, 2021 Results on Aug 05, 2021

2021-07-07 20:15:00

Regeneron Pharmaceuticals, Inc. announced that they will report Q2, 2021 results Pre-Market on Aug 05, 2021

Regeneron Pharmaceuticals, Inc., Q2 2021 Earnings Call, Aug 05, 2021

2021-07-07 20:15:00

Regeneron Pharmaceuticals, Inc., Q2 2021 Earnings Call, Aug 05, 2021

Regeneron Genetics Center Discovers GPR75 Gene Mutations That Protect Against Obesity

2021-07-01 18:05:00

Regeneron Pharmaceuticals, Inc. announced that scientists from the Regeneron Genetics Center have discovered rare genetic mutations in the GPR75 gene associated with protection against obesity. As reported in Science, almost 650,000 people were sequenced to find rare individuals with this genetic 'superpower,' providing new insights into the genetic basis of obesity. Potential therapeutics mimicking these genetic superpowers are being developed at Regeneron, utilizing its VelocImmune technologies and novel technologies from collaborators such as Alnylam Pharmaceuticals, Inc. It is estimated that more than one billion people could be suffering from obesity by 2030.1,2 Working with research collaborators, RGC scientists found that individuals who have at least one inactive copy of the GPR75 gene have lower BMI and, on average, tend to weigh about 12 pounds less and face a 54% lower risk of obesity than those without the mutation. Protective 'loss of function' mutations were found in about one of every 3,000 people sequenced. As part of the research that led to the finding, RGC scientists analyzed deidentified genetic and associated health data from 645,000 volunteers from the United Kingdom, U.S. and Mexico. The study, one of the Regeneron Genetics Center's largest to date, was conducted in collaboration with Geisinger Health System, New York Medical College, the Nuffield Department of Population Health at the University of Oxford and the National Autonomous University of Mexico using data from the Mexico City Prospective Study, Geisinger's MyCode Community Health Initiative and UK Biobank. The Regeneron team, collaborating with the labs of Dr. Schwartzman and Dr. Garcia at New York Medical College, then validated the finding in mice that were genetically engineered using Regeneron's VelociGene technology to lack copies of the GPR75 gene. Such mice gained 44% less weight than mice without the mutation when both groups were fed a high-fat diet. Building on the company's strengths in genetics-driven drug discovery and development, the company's scientists are pursuing multiple therapeutic approaches to target GPR75, including through antibodies, small molecules and gene silencing.