FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review

The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a contentious advisory committee meeting that could have broader implications for the industry.

Capricor has halted work on all other pipeline projects to concentrate resources on the deramiocel program, a move that has drawn criticism from at least one shareholder who is unhappy with the narrowed focus.

In separate news, Moderna announced positive Phase 3 results for its personalized mRNA cancer vaccine developed in partnership with Merck, highlighting continued optimism for mRNA‑based oncology approaches.

The story also notes that President Trump has nominated White House aide Heidi Overton to serve as FDA commissioner, and that the oral obesity market is heating up as Eli Lilly and Novo Nordisk intensify competition.