Capricor pivoted after an FDA advisory committee setback, saying it will seek approval using an amended Duchenne muscular dystrophy (DMD) submission that incorporates additional data and analyses. The company framed the FDA as “willing to review” the updated package, aiming to rescue the therapy by refining the indication after prior scrutiny focused on endpoints and the breadth of the approval request. Separately, Capricor shares surged as investors reacted to the company’s update strategy tied to new FDA discussions. The stock moves reflected market expectations that the revised submission could shift the review back toward primary efficacy questions in DMD rather than alternate clinical contexts. For the DMD pipeline, Capricor’s move underlines how regulators can refocus their evidentiary demands even when a sponsor has Phase 3 data, pushing companies to repackage results to better match endpoint hierarchies. It also increases near-term read-through value for other cell-therapy programs navigating strict endpoint interpretations in neuromuscular indications. The next step for the company is filing the amendment and progressing through FDA review timelines for the revised approach.