Capricor’s deramiocel gained a fresh investor tailwind after the company reported additional open-label extension results tied to Duchenne muscular dystrophy cardiomyopathy. The update followed an FDA green light to review the new evidence, renewing debate over whether the therapy can meet regulatory requirements. The company’s disclosure highlighted how responses may be maintained or re-established in certain patient groups, including outcomes observed after additional treatment phases. While the FDA’s position on endpoints remains central, the new data package is intended to strengthen the overall benefit argument. Capricor’s share reaction underscored how quickly regulatory interaction and endpoint framing can move sentiment in rare-disease cell therapy.