Capricor Therapeutics announced positive topline results from its pivotal Phase 3 HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting the primary functional endpoint and a key cardiac secondary endpoint. The data prompted an immediate market reaction, with shares jumping sharply after the readout. The trial showed statistically significant improvements in upper‑limb performance and left ventricular ejection fraction versus placebo. Capricor previously received a complete response letter from the FDA; the new data provide a path for a second approval attempt and further regulatory engagement. Company statements indicate Capricor will pursue resubmission steps and regulatory discussions. Regulators will now evaluate whether the new, larger Phase 3 dataset addresses prior concerns about the therapy’s durability and clinical effect.