Capricor announced positive topline results from its pivotal Phase 3 HOPE-3 study of deramiocel in Duchenne muscular dystrophy (DMD). The company reported that the trial met its primary endpoint and a key cardiac secondary endpoint, outcomes the firm says address both skeletal and cardiac manifestations of the disease. Capricor framed the readout as a path to resubmission after an earlier FDA rejection. The results revive regulatory discussions after the agency issued a complete response letter earlier this year; Capricor has already held follow-up meetings with FDA to agree next steps. Company statements and investor reactions show the data materially reshaped market expectations for the program and the company’s near-term regulatory strategy. Analysts and industry observers will be watching the full dataset and regulatory dialogue; the topline release is a milestone for cell- and exosome-based therapies in rare neuromuscular disease. Capricor said it will share detailed data in follow-up disclosures and pursue the regulatory path outlined with FDA.