Capricor said it will amend its biologics license application for deramiocel after the FDA opened a new path via additional data tied to an open-label extension in Duchenne muscular dystrophy. The company’s move reflects prior regulatory friction around endpoints and a shift in the indication it is pursuing. After a negative advisory committee vote, Capricor sought a narrower approval strategy aimed at limb function, with prior focus connected to DMD cardiomyopathy. The revised submission is intended to realign the development narrative with the primary efficacy endpoint FDA reviewers emphasized. The update sparked a sharp investor response as the prospect of restarting the regulatory conversation improved. Still, the company’s outcome depends on how the FDA weighs the supplemental analyses and whether they address the concerns raised in the initial complete response letter. For DMD stakeholders, the event highlights how endpoint framing and label scope can materially change the regulatory trajectory for advanced cell therapies, especially where confirmatory trials are still under discussion.