CAPR AdComm: Jul 29, 2026
Capricor Therapeutics · Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC).
✗ Panel voted 3-9 against
On Jul 29, 2026 the CTGTAC voted that available evidence did not support the effectiveness of Deramiocel for cardiomyopathy in Duchenne muscular dystrophy, 3 for, 9 against, 0 abstain. The vote is non-binding; the FDA makes the final decision by the Aug 22, 2026 PDUFA date. The voting question addressed a narrower (cardiomyopathy) indication than Capricor proposed; a separate discussion on upper-limb function was directionally supportive of the Phase 3 HOPE-3 data.
Meeting dateJul 29, 2026
CommitteeCTGTAC
CompanyCapricor Therapeutics
DrugDeramiocel (CAP-1002)
IndicationDuchenne muscular dystrophy (DMD)
Panel vote3 for · 9 against · 0 abstain: AGAINST
PDUFA dateAug 22, 2026
ApplicationBLA 125842
Result sourceCapricor press release (Jul 30 2026) →
Meeting noticeFDA Federal Register notice →
An advisory committee vote is a public panel review; it is advisory only; the FDA makes the final decision at the PDUFA date. All AdComm meetings →
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Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
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