Capricor Therapeutics Inc. announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel for the treatment of Duchenne muscular dystrophy (DMD). The randomized, double-blind, placebo-controlled study met both its primary endpoint, measuring skeletal function by PUL v2.0, and a key secondary cardiac endpoint, left ventricular ejection fraction (LVEF), achieving statistical significance with p-values of 0.03 and 0.04, respectively. Statistical significance was also achieved in all type 1 error controlled secondary endpoints. The safety and tolerability profile of Deramiocel remained favorable and consistent with previous clinical experience. These results have already been presented by the company, and Capricor plans to submit its response to a Complete Response Letter from the FDA, incorporating the HOPE-3 data.