Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy
CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy (SMA). Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improve
CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy (SMA). Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Salanersen is an investigational novel antisense oligonucleotide (ASO) and has the potential to offer high efficacy in SMA with once-yearly dosing.
Summary aggregated from GlobeNewswire's public RSS feed. The full reporting belongs to GlobeNewswire — please read it on their site.