Capricor Therapeutics moved to amend its biologics license application for deramiocel, seeking approval to improve limb function in Duchenne muscular dystrophy after the company previously faced a complete response letter. The company said on a call that it would shift the indication sought, following controversy over the primary regulatory endpoint focus in the Phase III HOPE-3 trial. The change targets limb function rather than DMD cardiomyopathy, an adjustment intended to realign FDA review priorities with clinical goals for patients. Capricor’s announcement followed a period of regulatory uncertainty for the platform. The stock reaction referenced in coverage suggests investors are re-assessing deramiocel’s regulatory odds under the revised label strategy, but the ultimate path remains contingent on FDA acceptance of the amended application and any requested data. For gene- and cell-therapy developers, the update shows how endpoint strategy and indication framing can drive regulatory engagement when a prior review stalled.