Capricor's Lead Duchenne Therapy Hits FDA Regulatory Roadblock

Capricor Therapeutics Inc. CAPR stock is trading lower on Friday. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for cardiomyopathy associated with Duchenne muscular dystrophy (DMD).In the CRL, the FDA stated that it had completed its application review but could not approve the BLA in its current form.The agency specifically cited that the BLA d ...