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Deramiocel (CAP-1002)

Duchenne Muscular Dystrophy (DMD)

Phase 3BLA SubmittedNCT05126758 (HOPE-3)

Key Facts

Indication

Duchenne Muscular Dystrophy (DMD)

Phase

Phase 3

Status

BLA Submitted

Company

Capricor Therapeutics, Capricor Therapeutics

About Capricor Therapeutics

Capricor Therapeutics is dedicated to developing novel cell and exosome-based therapies for serious rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). The company's lead asset, Deramiocel, is an allogeneic cardiac-derived cell therapy that has demonstrated significant functional benefits in late-stage clinical trials and is under regulatory review. Capricor's strategy leverages its two synergistic technology platforms—allogeneic cardiosphere-derived cells (CDCs) and the StealthX™ exosome platform—to build a diversified pipeline targeting high-unmet-need conditions.

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About Capricor Therapeutics

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Therapeutic Areas

Rare Diseases Neuromuscular Cardiology Infectious Disease

Other Duchenne Muscular Dystrophy (DMD) Drugs

Drug	Company	Phase	Status
DT-DEC01	Dystrogen Therapeutics	Phase 1	Active (Dose Escalation)
Skeletal Muscle Regeneration Program	IPS HEART	Pre-clinical	Active
KYMBEE (deflazacort)	Upsher-Smith	Approved	Active
ALY688ER	Allysta Pharmaceuticals	Phase 1	Active
AVGN7 + AVGND	AAVogen	Pre-clinical	Active
Myomatrix Stabilization Program	Strykagen	Preclinical	Active
RIPPLE™ (implied)	SonoThera	Preclinical	Active
Vamorolone (AGAMREE)	ReveraGen BioPharma	Approved	Active
AGAMREE (vamorolone)	Catalyst Pharmaceuticals	Marketed	Commercial; Long-term safety monitored via SUMMIT Registry
EDG-5506	Edgewise Therapeutics	Phase 2	Active
ELEVIDYS (delandistrogene moxeparvovec-rokl)	Sarepta Therapeutics	Marketed / Phase 3	FDA Accelerated Approval; Confirmatory trial ongoing
SRP-5051 (vesleteplirsen)	Sarepta Therapeutics	Phase 2	Active (Next-gen PPMO)