The company behind an experimental Duchenne muscular dystrophy cell therapy has changed what it is asking the Food and Drug Administration to approve. Capricor Therapeutics said it will file an amendment seeking a narrower indication centered on upper limb skeletal muscle function rather than the heart disease it had pursued for more than a year, and that the FDA has indicated it will extend the decision deadline once the amendment arrives.
That deadline is tomorrow. The current target action date for deramiocel is Aug. 22, 2026, and families who circled it on a calendar in July should expect it to move rather than produce an answer.
