FDA Extends Capricor’s Deramiocel Decision Date to November 22

Capricor Therapeutics said the FDA extended the PDUFA target action date for deramiocel, its investigational cell therapy for Duchenne muscular dystrophy, from August 22 to November 22, 2026.

The three-month extension follows Capricor’s submission of a major amendment to the biologics license application. The amendment includes 24-month open-label extension data from the Phase 3 HOPE-3 study and additional robustness analyses.

Capricor is asking the FDA to consider a narrower proposed indication focused on upper-limb function—the primary endpoint of HOPE-3—rather than a broader Duchenne indication.

The FDA’s Center for Biologics Evaluation and Research accepted the amendment for review, citing the significant unmet medical need in Duchenne. The agency needs additional time to evaluate the new information.

HOPE-3 previously met its primary endpoint:
Capricor reported that deramiocel slowed upper-limb function decline by 54% versus placebo. The therapy remains investigational and is not yet approved.

The update is viewed as a regulatory reprieve, not an approval. The November 22 date is the FDA’s target action date, and the agency could still approve, reject, or request further information.