FDA to Convene Experts for Capricor's DMD Therapy Review

Capricor Therapeutics has completed a mid-cycle review with the FDA for its investigational cell therapy, deramiocel, aimed at treating cardiomyopathy in patients with Duchenne muscular dystrophy (DMD). The FDA found no significant deficiencies during the review and plans to convene an advisory committee meeting, with a date yet to be set, before making a final decision by the target action date of August 31, 2025. Analysts and the company remain optimistic about deramiocel's prospects, emphasizing its potential to address an unmet need in DMD-related heart disease and noting that recent share price declines may be unwarranted. The upcoming advisory committee meeting is seen as an opportunity to further demonstrate the therapy's safety and efficacy, and analysts maintain positive outlooks for Capricor's stock. The FDA's continued progress on review timelines is notable amid general concerns about delays due to agency staffing changes. Overall, deramiocel is regarded as a potentially transformative therapy for a leading cause of death among DMD patients.