Capricor reported that its cell therapy deramiocel met the primary functional endpoint and a key cardiac secondary endpoint in a pivotal Phase 3 Hope-3 trial. The study showed statistically significant improvements in Performance of the Upper Limb v2.0 (p=0.03) and left-ventricular ejection fraction (p=0.04), results the company says address concerns from a prior FDA Complete Response Letter. The company said it will use the new, placebo-controlled data to seek a second regulatory path after the agency’s earlier rejection; Capricor also disclosed an agreement with the FDA on next regulatory steps following a July Type A meeting. Investors reacted sharply: shares jumped more than 300% on top-line results, reflecting renewed confidence in the program’s commercial potential. Analysts and company executives framed the readout as pivotal to reversing the agency’s earlier decision; Capricor’s leadership is positioning the data package to support submission and further engagement with regulators about approval requirements. The therapy’s dual cardiac and muscle effects make the study rare in Duchenne development, potentially changing regulatory and commercial calculus if sustained in confirmatory work.