Deramiocel

Deramiocel is an allogeneic cardiosphere-derived cell therapy developed by Capricor Therapeutics. The next event is the FDA decision on Deramiocel, on Nov 22, 2026 (source).

Also known as: CAP-1002
Company: Capricor Therapeutics (CAPR) · Developer
How it works: Allogeneic cardiosphere-derived cell therapy
Approved: Not approved in any market we track

Development by disease

Becker muscular dystrophy	Filed
Duchenne muscular dystrophy cardiomyopathy	Filed

Upcoming events

Firm dates · a specific day set by the company or regulator

Next 60 days

Nov 22
in 40 days
Deramiocel · FDA decision · Duchenne muscular dystrophy cardiomyopathy
Capricor Therapeutics (CAPR)·Source

Past results and milestones

Mar 10, 2026
The FDA lifted the previously issued Complete Response Letter from July 2025 and resumed review of the deramiocel BLA, assigning a new PDUFA target action date of August 22, 2026. Source
Dec 3, 2025
HOPE-3 met its primary endpoint (PUL v2.0 with 54% slowing of skeletal muscle progression, p=0.029) and key secondary cardiac endpoint (LVEF with 91% slowing of decline, p=0.041), with all secondary endpoints also achieving statistical significance. Source
Jul 11, 2025
FDA issued Complete Response Letter on July 11, 2025 declining approval. FDA stated BLA does not meet statutory requirement for substantial evidence of effectiveness and requires additional clinical data. Capricor plans resubmission in Q3 2025 with Phase 3 HOPE-3 data. Source

Trials

HOPE-3

The investment thesis, what each upcoming event depends on and the competitive landscape are on the Capricor Therapeutics page. Upcoming FDA decisions · All drugs