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- FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocelThe FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
- FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocelAn FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…