Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE-3 trial of deramiocel, the company’s cell- and exosome-based therapy for Duchenne muscular dystrophy (DMD). The study met its primary functional endpoint (Performance of the Upper Limb v2.0) and a key secondary cardiac endpoint (left-ventricle ejection fraction), according to the company release. The readout follows an earlier FDA complete response letter and a subsequent regulatory meeting that set a path for a resubmission. Company statements and regulatory filings show Capricor will pursue a second approval attempt informed by the larger, placebo-controlled Phase 3 data set. The results address both skeletal muscle and cardiac outcomes—two of the most scrutinized measures in DMD development—and the firm signaled it will press ahead with regulatory engagement. Investors reacted sharply: shares jumped upon the announcement, reflecting renewed market confidence in a previously contested program. Sources: Capricor press release, company filings and market disclosures.