Capricor Therapeutics said it will ask the FDA to review additional data after a negative vote from an advisory committee regarding its Duchenne muscular dystrophy cell therapy. The company framed the next step as an attempt to improve its likelihood of approval in a narrower intended indication. Capricor indicated it will file supplemental analyses and updated materials, aiming to address the committee’s questions and the basis for the negative recommendation. The move follows a sharp market reaction to CEO comments that the FDA was “willing to review” an amended submission. The development keeps Capricor’s program alive for a potential regulatory path even as it highlights how sensitive DMD manufacturing and clinical endpoint questions can be for regulators. Observers will be watching how Capricor characterizes efficacy, safety, and patient selection in the renewed materials.