Biogen’s salanersen receives FDA breakthrough therapy designation for spinal muscular atrophy

Biogen

4 June 2026 - Biogen announced today that the US FDA has granted salanersen breakthrough therapy designation for the treatment of spinal muscular atrophy.

The FDA’s decision is based on data from the Phase 1b study of salanersen, which were recently presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference and the 5th International Scientific Congress on spinal muscular atrophy.

Read Biogen press release

Michael Wonder

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Michael Wonder