FDA Extends Capricor’s Deramiocel Review, Sets Nov. 22 Action Date

The U.S. Food and Drug Administration extended its review of Capricor Therapeutics’ Deramiocel application by three months, setting a Nov. 22, 2026, target action date for the investigational Duchenne muscular dystrophy therapy.

The extension followed the FDA’s classification of an amendment to the biologics license application as major. The amendment includes two-year open-label extension data and additional analyses from the Phase 3 HOPE-3 trial, along with an integrated efficacy summary across HOPE-2 and HOPE-3.

The amendment proposed an indication focused on upper limb impairment in patients older than nine. Capricor CEO Linda Marbán said, “As we approach our PDUFA date, we remain confident in the strength of our data.”