ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) -- Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the first treatment authorized within the European Union specificall...
Biogen to Highlight Scientific Progress Across Alzheimer’s Disease at the Alzheimer’s Association International Conference 2025 Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued carePresentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Asso...
Biogen Announces $2 Billion Manufacturing Investment in North Carolina’s Research Triangle Park in Conjunction with its 30th Anniversary Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: BIIB) – today announced it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). Since breaking ground in 1995, Biogen’s manufacturing in RTP has played a vital role in delivering the compan...
Biogen and Stoke Therapeutics Announce Presentation of Data from Studies of Zorevunersen, an Investigational Medicine for Dravet syndrome, at the 16th European Paediatric Neurology Society (EPNS) Congress – Data from an analysis designed to evaluate the potential effects of the Phase 3 zorevunersen dosing regimen showed improvements in cognition and behavior at Week 68 – – These findings support the inclusion of key secondary endpoints assessing cognition and behavior in the Phase 3 EMPEROR study and contrast with outcomes observed in natural history data – CAMBRIDGE, Mass. and BE...
Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN)There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S.1Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated therapeutic candidate with promise for a broad range of immune-med...
New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg SPINRAZA® (nusinersen) Final results from the landmark NURTURE study highlight the profound impact of early treatment with 12 mg SPINRAZA in clinically presymptomatic SMA with 92% of children achieving the ability to walk independently CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWI...
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