The FDA extended its review of Capricor Therapeutics’ deramiocel, pushing the PDUFA decision timeline as the agency seeks additional information for a refined indication. Capricor said the regulator is reviewing updated data tied to the therapy’s use profile. The delay continues a high-attention regulatory sequence for deramiocel, with prior comments around clinical and label scope drawing scrutiny. Capricor’s updates aim to address the FDA’s requests and better define where the therapy may fit clinically. From an industry perspective, the extended review highlights how label refinements and new datasets can materially shift cell therapy review timelines and commercial planning.