Capricor Therapeutics (CAPR) provided regulatory updates related to its Biologics License Application, BLA, for Deramiocel, the Company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy, DMD,-associated cardiomyopathy. As part of the FDA’s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time. The BLA remains under Priority Review with a Prescription Drug User Fee Act, PDUFA, target action date of August 31, 2025.
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