FDA says Capricor’s Duchenne stem cell therapy missed Phase 3 trial goals
The U.S. Food and Drug Administration said Capricor Therapeutics’ stem cell treatment for Duchenne muscular dystrophy, deramiocel, did not meet the objectives of its Phase 3 trial. That contrasts with Capricor’s December statement that the therapy met both the primary and secondary endpoints in a large randomized study. The drug had been aimed at teenagers and young men who have already lost the ability to walk, a group with limited treatment options.