AdComm meeting scheduled for Capricor's deramiocel
- Sponsor
- Capricor Therapeutics $CAPR
- Drug
- deramiocel · human allogeneic cardiosphere-derived cells
- Indication
- Duchenne muscular dystrophy
FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet July 29, 2026 to review Capricor's BLA 125842 for deramiocel, an allogeneic cardiosphere-derived cell therapy for Duchenne muscular dystrophy. PDUFA target action date is August 22, 2026.
Read original at federalregister.gov ↗From the source
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public.
DATE: The meeting will be held on July 29, 2026, from 9 a.m. Eastern Time to 5:30 p.m. Eastern Time.
The committee will discuss BLA 125842 for deramiocel (human allogeneic cardiosphere-derived cells) submitted by Capricor, Inc., for the treatment of cardiomyopathy and skeletal muscle deterioration associated with Duchenne muscular dystrophy.
The PDUFA target action date for the application is August 22, 2026.
Reproduced from Federal Register — FDA Advisory Committees · view original · public domain or open-licensed government work