GlobeNewswire·Nov 9, 2026, 9:00 AM ET

Capricor’s HOPE-3 Phase 3 Cardiac Results for Deramiocel Win American Heart Association Outstanding Research Award in Pediatric Cardiology

Capricor Therapeutics announced that Deramiocel cardiac results from the HOPE-3 Phase 3 trial in Duchenne muscular dystrophy (DMD) received the Outstanding Research Award in Pediatric Cardiology at the AHA Scientific Sessions 2026 on November 7, 2026.
The HOPE-3 trial randomized 106 DMD patients to receive Deramiocel or placebo for 12 months 1 the primary endpoint of upper limb function was met.
Cardiac MRI data showed Deramiocel patients experienced a +1.8 percentage point increase in left ventricular ejection fraction (LVEF) versus placebo (p=0.09), while a natural history comparison showed a +2.3 percentage point increase (p=0.02).
In the prespecified cardiomyopathy subgroup, Deramiocel showed a +2.8 percentage point LVEF improvement versus placebo (p=0.02) and a +2.8 percentage point improvement versus natural history (p=0.01).
Patients treated with Deramiocel had 3.0 fewer new heart segments with scarring compared to placebo (p=0.02) 2.9 fewer compared to natural history (p=0.01), indicating slower scar progression.
The Biologics License Application for Deramiocel is under FDA review with a PDUFA target action date of November 22, 2026.
Deramiocel holds Orphan Drug, RMAT, 1 Rare Pediatric Disease, 1 ATMP, 1 1 European Orphan Drug designations for the treatment of DMD.