HHS spokesperson tells Reuters FDA ‘actively re-evaluating’ Capricor AdCom

An HHS spokesperson tells Reuters that the FDA is “actively re-evaluating” whether to proceed with the Advisory Committee meeting that had been planned to discuss Capricor Therapeutics (CAPR)’ Biologics License Application for Deramiocel, the company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy-associated cardiomyopathy. Capricor provided regulatory updates earlier today related to its BLA for Deramiocel and stated that as part of the FDA’s ongoing review, the company has been informed that an Advisory Committee meeting is not indicated at this time.