10 March 2026 - Capricor Therapeutics today announced that the US FDA has lifted the previously issued complete response letter and resumed review of its biologics license application seeking full approval of deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy cardiomyopathy.

The submission has been classified as a Class 2 resubmission, with a PDUFA target action date of 22 August 2026.

Read Capricor Therapeutics press release