FDA advisory panel votes 9-3 against Deramiocel effectiveness for DMD cardiomyopathy

CAPRICOR THERAPEUTICS, INC.

• FDA CTGT Advisory Committee voted 9-3 that evidence did not support Deramiocel's effectiveness for DMD cardiomyopathy; vote is non-binding.
• PDUFA target action date remains August 22, 2026; FDA will consider committee recommendation in BLA review.
• Committee's voting question addressed a narrower indication than Capricor proposed; no vote on overall benefit-risk.
• In separate discussion, committee gave directionally supportive feedback on upper limb function from HOPE-3 trial.
• CEO Linda Marbán expressed commitment to Deramiocel and confidence in HOPE-3 data; patients and families shared support.