CAMBRIDGE, Mass. – Biogen Inc. (Nasdaq: BIIB) announced that the first patient has been dosed in the global clinical study, TOPAZ-1. The Phase 3 study will evaluate the clinical efficacy and assess the safety of BIIB059, a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2...
treatment News
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) today announced that the High Dose Regimen of SPINRAZA® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10...
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...
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) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common...