# FDA Disputes Capricor Phase 3 Success for DMD Cell Therapy Deramiocel Ahead of AdCom

> fda · REPORTED · 2026-07-28

On July 28, 2026, FDA briefing documents for a July 29 advisory committee meeting disagreed with Capricor Therapeutics' assertion that its phase 3 trial of deramiocel, a cell therapy for cardiomyopathy in Duchenne muscular dystrophy, met its primary outcome, sending shares down as much as 70%. Capricor attributed the discrepancy to the FDA using a superseded statistical analysis plan.

About Capricor Therapeutics: Capricor Therapeutics is a clinical-stage biopharmaceutical company developing cell and gene therapies for Duchenne muscular dystrophy, with deramiocel being an allogeneic cardiosphere-derived cell therapy aimed at halting cardiac and skeletal muscle decline.

- Company: Capricor Therapeutics
- Sector: therapeutics
- Primary source: https://www.bioworld.com/articles/732926-argenx-expands-immune-pipeline-in-22b-cash-acquisition-of-forte

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.