CAMBRIDGE, Mass. – Biogen Inc. (Nasdaq: BIIB) today announced topline results from the Phase 3 STAR study of timrepigene emparvovec (BIIB111/AAV2-REP1), an investigational gene therapy for the potential treatment of choroideremia. The STAR study did not meet its primary endpoint of proportion of participants with a ≥15 letter improvement from...
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Cambridge, Mass. — Biogen Inc. (NASDAQ: BIIB) announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10 April 2023. Mr. Triano will report to Michael McDonnell, Executive Vice President and Chief Financial Officer. “Chuck will bring invaluable industry insights and a strong network of...
Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated therapeutic candidate with promise for a broad range of immune-mediated diseases Biogen is initiating three pivotal Phase 3 studies of felzartamab across rare kidney indications in 2025, with first readout expected in 2027 CAMBRIDGE, Mass. – Biogen Inc. (Nasdaq: BIIB) will host...
Global Phase 3 BRAVE study will evaluate the efficacy and safety of omaveloxolone in children 2 to <16 years old with Friedreich ataxia, a rare neurodegenerative disorder BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population Omaveloxolone is currently marketed under...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately...
CAMBRIDGE, Mass. – Biogen Inc. (Nasdaq: BIIB) today announced plans to initiate a global Phase 3b clinical study, ASCEND. The ASCEND study is designed to evaluate the clinical outcomes and assess the safety of a higher dose of nusinersen* in children, teens and adults with later-onset spinal muscular atrophy (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...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. SKYCLARYS is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease. “In...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) – will present new data from its felzartamab clinical development programs at Kidney Week 2025, the American Society of Nephrology’s (ASN) annual meeting, taking place November 5-9 in Houston, Texas. Felzartamab, an investigational anti-CD38 monoclonal antibody, is currently being evaluated in three pivotal Phase...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a...