Capricor Therapeutics moved to salvage its deramiocel FDA filing after a negative advisory committee outcome by planning to amend the BLA and seek reconsideration focused on an updated DMD indication. In parallel, the company said it will ask the FDA to review additional data and analyses to support a narrower clinical claim. The recap of FDA engagement comes after the company’s stock reaction to indications that an open-label extension can be used to support the application, with the company aiming to re-center the agency’s review on a primary clinical endpoint tied to limb function rather than secondary measures that previously drove concern. For DMD cell therapy developers, the storyline highlights how trial evidence and indication framing can swing agency review dynamics, especially when prior submissions faced complete response outcomes.