FDA has delayed its decision date for Capricor Therapeutics’ deramiocel, extending the agency’s review of the Duchenne muscular dystrophy program after the company submitted updated information for a refined indication. The move pushes the PDUFA timeline further as FDA evaluates additional datasets. In parallel, FDA also extended review of Capricor’s cell therapy and indicated it is focusing on an updated application with a more targeted label. Capricor’s deramiocel is based on the company’s cardiosphere-derived cell platform, which is being positioned for specific patient subgroups. For Capricor and the broader cell-therapy field, the extension signals continued regulatory focus on clinical evidence strength and label specificity, especially for cell products seeking expanded or more niche indications.