# FDA Extends Deramiocel PDUFA Date by Three Months to November 22, 2026

> fda · REPORTED · 2026-08-24

The FDA extended the PDUFA target action date for Capricor's deramiocel BLA for Duchenne muscular dystrophy from August 22 to November 22, 2026, classifying the submission as a major amendment following previously issued negative briefing documents from FDA reviewers.

About Capricor Therapeutics: Capricor Therapeutics is a clinical-stage biopharmaceutical company developing cell therapy treatments for Duchenne muscular dystrophy and other rare diseases.

- Company: Capricor Therapeutics
- Sector: therapeutics
- Primary source: https://www.sec.gov/Archives/edgar/data/0001133869/000110465926100071/capr-20260824x8k.htm

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