Capricor says FDA advisers vote 9-3 against Deramiocel effectiveness in DMD cardiomyopathy

Capricor disclosed FDA advisers voted 9-3 that evidence did not support Deramiocel’s effectiveness for Duchenne muscular dystrophy-related cardiomyopathy; the vote was non-binding.

Upper-limb function discussion was more supportive, citing Phase 3 HOPE-3 evidence on skeletal muscle benefit; no separate benefit-risk vote occurred.

Results have already been presented to the advisory committee; a final FDA decision is due by the Aug. 22, 2026 PDUFA action date.