# Deramiocel (CAP-1002) PDUFA Event: Duchenne muscular dystrophy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/CAPR/deramiocel-duchenne-muscular-dystrophy-review-2

Ticker: CAPR

Company: Capricor Therapeutics

Event date: 2026-11-22

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

Review cycle: 2

FDA decision expected after review extension. FDA extended the PDUFA target action date for the deramiocel BLA from August 22 to November 22, 2026 after acce...

## Event Timeline

### November 22, 2026 — FDA decision expected after review extension

FDA extended the PDUFA target action date for the deramiocel BLA from August 22 to November 22, 2026 after accepting a major amendment containing HOPE-3 open-label-extension data and additional analyses.

[Capricor — Deramiocel PDUFA extension](https://www.capricor.com/investors/news-events/press-releases/detail/354/capricor-therapeutics-announces-extension-of-pdufa-target)

### July 29, 2026 — FDA advisory committee reviewed the BLA

FDA convened the Cellular, Tissue and Gene Therapies Advisory Committee to review deramiocel. The committee's vote on substantial evidence for the originally proposed cardiomyopathy indication was 3 in favor and 9 against.

[Capricor — Second-quarter regulatory update](https://www.capricor.com/investors/news-events/press-releases/detail/353/capricor-therapeutics-reports-second-quarter-2026-financial)

### March 12, 2026 — FDA resumed review of the Class 2 BLA resubmission

FDA accepted Capricor's response to the prior Complete Response Letter as a Class 2 resubmission and set the original August 22, 2026 action date.

[Capricor — BLA review resumed](https://www.capricor.com/investors/news-events/press-releases/detail/340/capricor-therapeutics-reports-fourth-quarter-and-full-year)

### December 3, 2025 — HOPE-3 reported positive pivotal results

Deramiocel met the Phase 3 HOPE-3 primary endpoint for upper-limb function in Duchenne muscular dystrophy.

[Capricor — Positive HOPE-3 topline results](https://www.capricor.com/investors/news-events/press-releases/detail/331/capricor-therapeutics-announces-positive-topline-results)

## Related Pages

- CAPR PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/CAPR.md

- CAPR company profile: https://biopharmsignal.com/company/CAPR.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-05 — Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-presents-positive-hope-3-open-label-extension-data-on-uppe-661c1be7.md

- 2026-09-17 — Capricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society Congress: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-to-present-hope-3-and-hope-3-open-label-extension-data-at--ee57afc6.md

- 2026-08-24 — Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-announces-extension-of-pdufa-target-action-date-as-fda-con-60ca4187.md

- 2026-08-13 — Capricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-reports-second-quarter-2026-financial-results-and-provides-a191d249.md

- 2026-08-10 — Capricor Therapeutics to Report Second Quarter 2026 Financial Results and Provide Recent Corporate Update on August 13: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-to-report-second-quarter-2026-financial-results-and-provid-65f22441.md