Capricor reported positive topline results from the pivotal Phase 3 HOPE-3 trial of deramiocel in Duchenne muscular dystrophy (DMD), hitting both its primary muscle endpoint and a key cardiac secondary endpoint. The company announced the data in a press release and investors responded immediately, driving a sharp rally in Capricor stock. The readout follows an earlier FDA rejection and represents Capricor’s attempt to reverse that decision with a larger, placebo-controlled dataset. The HOPE-3 trial showed statistically significant improvements in Performance of the Upper Limb v2.0 and left ventricular ejection fraction, according to company statements and regulatory filings. Capricor has discussed next regulatory steps with the FDA after receiving prior guidance and is positioning the new dataset to support a second approval attempt. Analysts and investors are parsing whether the Phase 3 profile addresses the agency’s earlier concerns; company management says the larger, controlled results should materially change the regulatory calculus. The outcome is likely to trigger follow-up interactions with regulators and shape the firm’s commercial planning for DMD-related cardiac indications.