Capricor Therapeutics received a Complete Response Letter from the FDA rejecting its biologics license application for deramiocel, an allogeneic cell therapy aimed at treating cardiomyopathy in Duchenne muscular dystrophy (DMD). The agency cited insufficient evidence of efficacy and outstanding chemistry, manufacturing, and control issues. Capricor expressed surprise given prior regulatory flexibility in the DMD space and plans to await pivotal Phase III trial data before proceeding. The decision caused a significant drop in the company’s stock price and raises questions about evolving FDA review standards for gene and cell therapies.