The FDA extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy deramiocel, deferring a decision after a negative advisory committee vote earlier in 2026. The agency asked for additional information tied to a refined indication and data package. Separately, the FDA pushed back Capricor’s PDUFA date again to review newly submitted information, underscoring the agency’s continued need to resolve issues raised during the application cycle. For developers, such timing shifts often affect financing, launch planning, and the clinical evidence narrative. Capricor framed the FDA’s deferral as a continued path for the program while it works through the agency’s request. The process remains closely watched by DMD-focused investors because deramiocel is positioned for a potentially broader population than earlier iterations. Overall, the FDA’s handling of the deramiocel review highlights ongoing scrutiny around cell therapy efficacy, safety, and indication refinement as sponsors iterate applications.