FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
AdComrejectedderamiocelNegative
AI Analysis
Summary
FDA advisory committee voted 9-3 against approval of Capricor's deramiocel for DMD, citing very fragile data on cardiac function from the Phase 3 HOPE-3 trial. The negative recommendation represents a significant setback for the therapy's path to market approval.
Clinical Trial Data
Phase
Phase 3
Outcome Details
Advisory committee voted 9-3 against approval; FDA reviewers cited 'very fragile' data on secondary endpoint of cardiac function from Phase 3 HOPE-3 trial
Importance:8/10
Sentiment:
-0.95
FDA advisory committeeDMD therapynegative votecardiac functionHOPE-3 trial
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Published by BioSpace on July 29, 2026 10:43 PM