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

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

Ticker: CAPR

Company: Capricor Therapeutics

Event date: 2026-08-22

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

Review cycle: 2

FDA decision expected. PDUFA target action date for the Class 2 resubmission of the deramiocel BLA.

## Event Timeline

### August 22, 2026 — FDA decision expected

PDUFA target action date for the Class 2 resubmission of the deramiocel BLA.

[Capricor — FDA resumed review and established the new PDUFA date](https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa)

### July 29, 2026 — CTGTAC voted 9–3 against effectiveness

The FDA advisory committee voted 9–3 that the available evidence did not establish deramiocel's effectiveness for cardiomyopathy in Duchenne muscular dystrophy. The recommendation is non-binding and the FDA decision remained pending.

[FDA — July 29 CTGTAC meeting materials and webcast](https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-july-29-2026-meeting-announcement-updated)

### March 10, 2026 — FDA resumed review of the BLA

FDA accepted the response to the CRL as a complete Class 2 resubmission and assigned an August 22, 2026 target action date.

[Capricor — New PDUFA date for the deramiocel resubmission](https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa)

### December 3, 2025 — HOPE-3 met its primary and key cardiac endpoints

The randomized Phase 3 study met the PUL v2.0 primary endpoint and the LVEF key secondary endpoint, with statistical significance also reported across all Type I error-controlled secondary endpoints.

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

### July 11, 2025 — FDA issued a Complete Response Letter

FDA did not approve the original BLA and requested additional clinical evidence. Capricor planned to address the letter with data from the ongoing HOPE-3 trial.

[Capricor — Complete Response Letter for the original BLA](https://www.capricor.com/investors/news-events/press-releases/detail/319/capricor-therapeutics-provides-regulatory-update-on)

### June 22, 2022 — Phase 3 HOPE-3 study started

The pivotal HOPE-3 study began enrolling patients with Duchenne muscular dystrophy to evaluate deramiocel's effect on skeletal and cardiac function.

[ClinicalTrials.gov — HOPE-3 study record (NCT05126758)](https://clinicaltrials.gov/study/NCT05126758)

## Regulatory Designations

- Priority Review FDA: [Capricor — Priority Review and August 22 PDUFA date](https://www.capricor.com/investors/news-events/press-releases/detail/343/capricor-therapeutics-takes-legal-action-to-protect-patient)

## 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

- 2026-08-24 — 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

- 2026-07-30 — Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel: https://biopharmsignal.com/news/CAPR/capricor-therapeutics-provides-update-on-fda-advisory-committee-meeting-for-dera-ef1c36a3.md

- 2026-07-29 — The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy: https://biopharmsignal.com/news/CAPR/the-lancet-publishes-hope-3-data-for-capricor-therapeutics-deramiocel-in-duchenn-9e6e6bd9.md