Capricor moved to recalibrate its Duchenne muscular dystrophy regulatory strategy after an FDA advisory committee setback, saying it will ask for review of additional data and analyses. The company’s intent is to improve prospects for approval by narrowing the indication back toward an endpoint focused on limb function. The change comes after prior discussions around its deramiocel BLA, which had been derailed by an advisory committee focus on a secondary endpoint. Capricor’s latest approach is positioned as a way to address the FDA’s concerns and restart momentum toward a potential submission amendment. Investors and clinicians will be watching whether the added package meaningfully addresses the endpoint disagreements that previously stalled the review, and how FDA frames the remaining evidence requirements for BLA approval in DMD.