Capricor Therapeutics is pressing for a regulatory path forward for deramiocel after an FDA advisory committee setback in Duchenne muscular dystrophy. The company says it will seek an FDA review of additional data and pursue changes intended to narrow the approval indication toward improved limb function, following a complete response letter history. Separately, Capricor disclosed that the US FDA is “willing to review” an updated submission, and the company signaled it expects to file additional supporting analyses and data. Market coverage also describes an open-label extension plan and renewed investor focus on whether the updated package can reframe the primary endpoint issue that previously derailed the application. The next regulatory steps will determine whether deramiocel can return to a viable approval trajectory in DMD beyond earlier differentiation challenges.