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Biogen Says FDA Grants Salanersen Breakthrough Therapy Designation For Treatment Of Spinal Muscular Atrophy
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  • 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 initiation of salanersen
  • Salanersen is an investigational antisense oligonucleotide dosed once-yearly with the potential to be a meaningful therapy in the future SMA treatment landscape

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.

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