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FDA grants breakthrough therapy status to Biogen's salanersen for spinal muscular atrophy treatment

Market News
04 Jun 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

Biogen's investigational drug salanersen received FDA Breakthrough Therapy Designation for treating spinal muscular atrophy (SMA), based on Phase 1b study results showing improved motor function and slowed neurodegeneration in children with suboptimal response to prior gene therapy. Salanersen, administered once yearly, offers potential high efficacy and is currently in Phase 3 trials targeting various SMA patient groups. This designation accelerates development and review, highlighting the urgent unmet needs in SMA treatment and Biogen's commitment to advancing new therapies.

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