Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE-3 trial of deramiocel, meeting the trial’s primary motor endpoint and a key cardiac secondary endpoint. The company said the study showed statistically significant improvements in Performance of the Upper Limb v2.0 and left ventricular ejection fraction, data the firm and investors view as a potential rebuttal to a prior FDA complete response letter. The readout prompted a dramatic market reaction, reflecting investor belief that the new, larger placebo‑controlled data could reopen regulatory discussions after the agency previously found the evidence insufficient. Capricor plans to use the Phase 3 results to support a fresh pathway toward approval and has signaled regulatory engagement to clarify next steps. The trial and company statements were disclosed in a company press release and subsequent market reports.