Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting the study’s primary functional endpoint and a key cardiac secondary measure. The company said treated patients showed improved upper‑limb performance and left‑ventricular ejection fraction compared with placebo. The readout follows an earlier FDA rejection and sets up a second approval attempt. Bristol‑filed regulatory interactions and a prior complete response letter had cast doubt on deramiocel’s approval path; Capricor says the larger, placebo‑controlled HOPE‑3 dataset addresses prior concerns. The company is engaging regulators on next steps and messaging to investors, while its stock climbed sharply on the data release. The therapy is an exosome‑based cell product intended to deliver immunomodulatory, anti‑fibrotic and pro‑angiogenic effects. If regulators accept the new data package, deramiocel could become a first treatment option for DMD patients with both cardiac and skeletal muscle involvement. Ongoing regulatory exchanges will determine timing of any resubmission and the pathway to market.