Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy

▤ Summary

Capricor Therapeutics faces another FDA hurdle as the agency schedules an advisory committee meeting for its Duchenne muscular dystrophy cardiomyopathy therapy, deramiocel. The company had expected a smoother review after strong Phase 3 results and a March resubmission acceptance. The decision raises fresh uncertainty ahead of the August target action date, even though management says it has not received specific concerns from regulators. The story also highlights broader FDA scrutiny in the DMD space and the potential impact of recent advisory committee activity on rare disease approvals.

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