Biogen's Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy

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 …

Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy

Designation is supported by an exploratory analysis from the Phase 1b study showing that some children with SMA previously treated with gene therapy who had suboptimal clinical status experienced slowing of neurodegeneration and clinically meaningful improvements in motor function following…

FDA names Biogen's salanersen a breakthrough therapy for SMA

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to salanersen, a new, more potent Biogen treatment for spinal muscular atrophy (SMA) that’s now in late-stage testing. The treatment candidate, being evaluated in two ongoing Phase 3 clinical trials, is similar to — but requires fewer doses than — Biogen’s Spinraza (nusinersen), the first approved therapy for SMA. The FDA awards breakthrough status to experi…

Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

Biogen has received the breakthrough therapy designation from the FDA for salanersen (BIIB115), an investigational treatment for SMA.The post Biogen’s salanersen gains FDA breakthrough therapy designation for SMA appeared first on Hospital Management.