Clinical TrialJul 29, 2026, 10:09 AM
Capricor Deramiocel Phase 3 Results Published in The Lancet; 54% Decline Slowing
AI Summary
Capricor Therapeutics announced that The Lancet has published positive results from its pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel for Duchenne muscular dystrophy (DMD). The trial met its primary endpoint, demonstrating a 54% slowing of upper limb function decline and showing clinically meaningful cardiac benefits. This independent peer-reviewed publication validates the trial's design and findings, reinforcing the company's Biologics License Application (BLA) which is currently under active FDA review with a PDUFA target action date of August 22, 2026.
Key Highlights
- Deramiocel Phase 3 HOPE-3 trial results published in The Lancet.
- Met primary endpoint, slowing upper limb function decline by 54% (p=0.03).
- Trial (n=106) showed clinically meaningful cardiac benefit.
- Publication provides external validation of trial design, methodology, and findings.
- Deramiocel BLA remains under active FDA review.
- PDUFA target action date for Deramiocel is August 22, 2026.
- First Phase 3 trial to show significant functional benefit in non-ambulatory DMD.
Price Impact
More from CAPR