Capricor Therapeutics reported that its cell therapy deramiocel met the dual efficacy goals of a placebo-controlled Phase 3 trial in Duchenne muscular dystrophy (DMD), showing statistically significant improvements in both skeletal muscle and cardiac function. The company said the results could alter the regulatory calculus after the FDA initially declined approval based on earlier mixed data. CEO Linda Marbán indicated the larger, controlled dataset should address prior agency concerns and urged that the new evidence could reverse earlier determinations. The therapy’s path now hinges on regulatory discussions and whether the FDA will reconsider its prior rejection in light of the new Phase 3 outcomes. The DMD space remains clinically urgent and commercially contested; a positive regulatory decision for deramiocel would add a cell therapy option to an ecosystem that includes gene and oligonucleotide approaches.