Capricor's BLA for Duchenne therapy receives FDA Complete Response Letter

The FDA issued a Complete Response Letter to Capricor for its BLA, prompting the company to plan resubmission with Phase 3 trial data in Q3 2025. The FDA cited a lack of substantial evidence of effectiveness and the need for additional clinical data, offering a Type A meeting for next steps. Capricor remains committed to pursuing approval for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy, engaging with the FDA for further discussions. The Phase 3 HOPE-3 trial, with topline results expected in Q3 2025, aims to provide additional evidence of effectiveness for Deramiocel, Capricor’s lead cell therapy candidate.

(Source: Globe Newswire)

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