Capricor Therapeutics reported that its cell therapy deramiocel met the primary endpoints in a Phase 3 trial, showing statistically significant improvements in both cardiac and skeletal muscle function in Duchenne muscular dystrophy (DMD) patients. The company said the dual outcome fulfills the study’s goals and strengthens the case for resubmission after an earlier FDA rejection. Capricor’s CEO Linda Marban indicated the new, larger placebo-controlled data could reverse the agency’s prior decision; company plans include renewed regulatory engagement. The therapy’s mechanisms, trial design, and clinical durability will be focal points in discussions with regulators. Investors and competitors will watch whether these results shift the regulatory calculus for cell therapies in rare neuromuscular disease.