Capricor said it will ask the FDA to review additional data for deramiocel after a prior negative FDA advisory committee vote, aiming to improve the company’s chances for approval in a narrower Duchenne muscular dystrophy setting. The company framed its next step around submitting further analyses and information following the advisory outcome, which previously derailed a proposed approval pathway focused on specific endpoints and indications. Capricor’s position reflects how label language and endpoint strategy remain pivotal in cell therapy regulatory decisions for muscular dystrophies, where benefit-risk assessments depend heavily on clinically meaningful functional measures. The update comes as investors react to renewed prospects and as Capricor continues efforts to align its submission with the FDA’s expectations for its Phase III HOPE-3-based program.