Capricor announced positive topline results from the pivotal Phase 3 HOPE-3 trial of deramiocel, showing statistically significant improvements in both upper-limb performance and a key cardiac endpoint. The company reported the data publicly and shares jumped sharply, reflecting investor optimism. The readout follows a prior FDA complete response and a Type A meeting that had left the therapy's approval path uncertain. Capricor says the new data bolster its case and that it will pursue regulatory steps toward resubmission, highlighting the therapy’s dual skeletal and cardiac effects. Industry sources note the dataset may force a reassessment of the earlier FDA stance if regulators accept the larger, placebo-controlled results.