Capricor's DMD Therapy Gets Another Extension as Moderna Vaccine Shines

Capricor Therapeutics has been working to bring its cell therapy for Duchenne muscular dystrophy, known as deramiocel, to market since last year when it received a first rejection from the FDA. The company resubmitted its application and the FDA accepted it, with a PDUFA date set for this past weekend. However, the agency granted a three-month extension after a contentious advisory committee meeting that may have implications for the broader industry.

Meanwhile, Moderna released promising Phase 3 results for its Merck-partnered personalized mRNA-based cancer vaccine, being trialed in combination with Keytruda for melanoma. The readout was highly anticipated and came ahead of schedule, nearly doubling Moderna's stock on the day of the announcement.

At the FDA, Trump has nominated White House aide Heidi Overton to be its next permanent leader. Analysts say she could be good for psychedelics and new pain meds but bad for vaccines.