FDA extends deramiocel review as Capricor narrows Duchenne claim

USA-based cell therapy developer Capricor Therapeutics (Nasdaq: CAPR) has been handed a three-month delay to the US Food and Drug Administration's (FDA) decision on deramiocel, its lead candidate for Duchenne muscular dystrophy (DMD), with the target action date moving from August 22 to November 22.

The San Diego company said it had filed an amendment to its Biologics License Application containing 24-month open-label extension data from the pivotal Phase III HOPE-3 trial, along with what it described as additional robustness analyses. The submission asks the agency to weigh both existing and new evidence behind a narrower proposed indication centered on upper limb function.