FDA Approval for VUMERITY issued to BIOGEN INC

Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMRAMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S1Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen's late-stage immunology portfolio CAMBRIDGE, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) – announced the initiation of dosing in the global clinical study, TRANSCEND. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen"), Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ", Biogen", ) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November 2024.1 Following CHMP's reaffirmation, after having considered the additional information requested by the European Commission (EC

Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights Collaboration broadens Biogen's rare disease pipeline and leverages global expertise commercializing high-value, disease-modifying medicines for rare genetic diseases Pivotal Phase 3 EMPEROR study of zorevunersen on track to initiate in Q2 2025 with an anticipated readout in 2H 2027 Stoke to receive $165M upfront, shared development costs and is eligible to receive up to $385M in milestones as well as royalties Biogen Inc. (NASDAQ:BIIB) and Stoke Therapeutics, Inc. (NASDAQ:STOK) today announced a collaboration for the development and

Bernstein initiated coverage of Biogen with a rating of Mkt Perform and set a new price target of $160.00

Piper Sandler downgraded Biogen from Overweight to Neutral and set a new price target of $138.00 from $315.00 previously

BMO Capital Markets downgraded Biogen from Outperform to Market Perform and set a new price target of $164.00 from $230.00 previously

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Submission status for BIOGEN INC's drug VUMERITY (ORIG-1) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/12/2024. Application Category: NDA, Application Number: 761347, Application Classification: Type 3 - New Dosage Form

Submission status for BIOGEN INC's drug VUMERITY (SUPPL-17) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/11/2024. Application Category: NDA, Application Number: 211855, Application Classification: Manufacturing (CMC)

Submission status for BIOGEN INC's drug VUMERITY (SUPPL-15) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 03/22/2024. Application Category: NDA, Application Number: 211855, Application Classification: Labeling

Cardurion Pharmaceuticals, Inc. ("Cardurion"), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of cardiovascular diseases, today announced that Charlotte (Charlie) Newman has joined the company as Chief Business Officer. A biopharmaceutical industry executive with over 25 years of industry experience, Ms. Newman most recently led corporate, portfolio and program strategy and business development as Chief Business Officer of Agios Pharmaceuticals (NASDAQ:AGIO), and previously held strategic product and portfolio roles at Biogen (NASDAQ:BIIB). In her role at Cardurion, she will be responsible for leading corporate development, bus

CAMBRIDGE, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) has appointed Daniel Quirk, M.D., M.P.H., M.B.A. as Chief Medical Officer and Head of Medical Affairs, effective October 28, 2024. Dr. Quirk will report to Priya Singhal, M.D., M.P.H., Head of Development at Biogen. "At Biogen, scientific and medical leadership is the foundation for everything we do, and this is why we believe Dan will be a perfect fit to lead our Medical Affairs organization going forward," said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. "With his diverse background in medicine, public health, and business administration, and his extensive experience in medical affairs

CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- The Biogen Inc. (NASDAQ:BIIB) Board of Directors (the "Board") today announced the appointments of two new independent directors, Lloyd B. Minor, M.D., effective October 1, 2024, and Sir Menelas (Mene) Pangalos, Ph.D., effective January 1, 2025. Dr. Minor is currently the Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford University, and Prof Sir Pangalos was most recently Executive Vice President of Biopharmaceuticals R&D at AstraZeneca until his retirement in April 2024. "We welcome Lloyd and Mene to our Board as they add significant experience and proven track records in leading R&D

Grew fourth quarter 2024 revenues1 to $95.3 million Expanded fourth quarter 2024 adjusted gross margins1,2 to 70% Generated fourth quarter 2024 adjusted net income2 of $16.8 million FY 2025 revenue guidance of $350M to $360M, exome/genome volume and revenue growth of at least 30% GeneDx to host conference call today at 8:30 a.m. ET GeneDx Holdings Corp. (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the fourth quarter and full year of 2024. "The fourth quarter capped an outstanding year for GeneDx, as we work to end the diagnostic odyssey with earlier intervention using our industry-leading exome and gen

CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs). "We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a promising late-stage therapeutic candidate being studied in multiple indications," said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. "With the transaction now complete, we will begin working together with our colleagues from HI-Bio on plans to advance felzart

Reata acquisition bolsters Biogen's rare disease portfolio with the addition of SKYCLARYS® (omaveloxolone), the first and only FDA approved treatment for Friedreich's ataxia in the U.S. CAMBRIDGE, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) – has completed the acquisition of Reata Pharmaceuticals, Inc. (NASDAQ:RETA), a company focused on developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. As a result of the transaction, Biogen has now acquired SKYCLARYS® (omaveloxolone), as well as other clinical and preclinical pipeline programs. SKYCLARYS®, Reata Pharmaceuticals' lead asset, was approved for the treatment of

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