Capricor said it will amend its BLA for deramiocel following an FDA advisory committee controversy, aiming to move the therapy into a narrower indication tied to improved limb function in Duchenne muscular dystrophy. The company said the FDA is willing to review updated data, and the move lifted Capricor shares sharply. Capricor previously faced a complete response posture after the advisory committee emphasized secondary trial endpoint concerns. The new plan attempts to re-align the development program with the primary functional outcome regulators historically prioritize in BLA decisions for DMD. The update puts additional focus on deramiocel’s open-label extension (OLE) data, while leaving the company with more regulatory work to complete before approval. For the field, the case underscores how indication strategy can reframe regulatory engagement after an adcomm reversal.