Capricor Therapeutics has received a complete response letter (CRL) from the FDA rejecting its Biologics License Application (BLA) for deramiocel, an off-the-shelf cell therapy aimed at treating cardiomyopathy in Duchenne muscular dystrophy patients. The FDA cited insufficient evidence of effectiveness and outstanding chemistry, manufacturing, and controls (CMC) issues. Capricor expressed surprise at the decision, which has led to a significant drop in its stock price. The outcome raises concerns about the regulatory environment for cell and gene therapies.