Sep 24, 2025 • Zacks Commentary
SOMEWHAT-BULLISH
BIIB's sNDA for Higher Dose of SMA Drug Spinraza Gets FDA's CRL
FDA issues CRL to Biogen's regulatory filing seeking approval for a higher dose of SMA drug, Spinraza. The company plans prompt resubmission.
Sep 23, 2025 • GlobeNewswire
NEUTRAL
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen
CAMBRIDGE, Mass., Sept. 23, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) today announced that the U.S. Food and Drug Administration ( FDA ) issued a Complete Response Letter ( CRL ) for the Company's supplemental New Drug Application ( sNDA ) for the high dose regimen of nusinersen for ...
Sep 23, 2025 • Benzinga
NEUTRAL
Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen - Ionis Pharmaceuticals ( NASDAQ:IONS ) , Biogen ( NASDAQ:BIIB )
CAMBRIDGE, Mass., Sept. 23, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. BIIB today announced that the U.S. Food and Drug Administration ( FDA ) issued a Complete Response Letter ( CRL ) for the Company's supplemental New Drug Application ( sNDA ) for the high dose regimen of nusinersen for the ...
Sep 23, 2025 • Zacks Commentary
SOMEWHAT-BULLISH
IONS' Rare Neurological Disease Drug Meets Late-Stage Study Goal
Ionis' zilganersen hits its phase III goal in Alexander disease, paving the way for a potential FDA filing in early 2026.
Sep 22, 2025 • Benzinga
NEUTRAL
Ionis Pharmaceuticals Reveals 'Unprecedented Results' From Rare Neurological Disease Trial - Ionis Pharmaceuticals ( NASDAQ:IONS )
Ionis Pharmaceuticals, Inc. IONS released topline results on Monday from the pivotal study of zilganersen in children and adults living with Alexander disease ( AxD ) , a rare, progressive, and often fatal neurological condition.
Sep 18, 2025 • GlobeNewswire
NEUTRAL
Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates
CAMBRIDGE, Mass., Sept. 18, 2025 ( GLOBE NEWSWIRE ) -- Biogen Inc. ( Nasdaq: BIIB ) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ...