Opportunity
Federal Register #FDA-2026-N-6771
FDA Advisory Committee Meeting for Capricor, Inc.'s Deramiocel Biologics License Application
Buyer
Food and Drug Administration
Posted
June 29, 2026
Respond By
July 21, 2026
Identifier
FDA-2026-N-6771
This notice announces a public advisory committee meeting organized by the Food and Drug Administration (FDA), under the Department of Health and Human Services. - Purpose: To discuss and make recommendations regarding Biologics License Application (BLA) 125842 submitted by Capricor, Inc. - Product under review: Deramiocel, a human allogeneic cardiosphere-derived cell therapy intended for treating cardiomyopathy in Duchenne muscular dystrophy. - OEM highlighted: Capricor, Inc. is the sole manufacturer and applicant mentioned. - No procurement action: The notice does not request or solicit any products or services, and no purchase quantities or part numbers are provided. - Public participation: The FDA is inviting public comments and participation in the regulatory review process through a public docket. - No unique procurement requirements or contract vehicles are specified.
Description
The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to discuss and make recommendations on Biologics License Application (BLA) 125842 from Capricor, Inc. for deramiocel, a treatment for cardiomyopathy in Duchenne muscular dystrophy. The meeting will be held virtually on July 29, 2026, from 10:00 a.m. to 4:30 p.m. Eastern Time and is open to the public. FDA is establishing a docket for public comment on this document, with comments due by July 21, 2026.