---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-025657"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-03-10T23:59:59+00:00"
generated_at: "2026-05-15T15:29:47.854558+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts CRL for Deramiocel BLA; new PDUFA date August 22, 2026

## Summary
- FDA resumed review of Deramiocel BLA for Duchenne muscular dystrophy cardiomyopathy after lifting CRL.
- Submission classified as Class 2 resubmission; PDUFA target action date set for August 22, 2026.
- BLA supported by positive HOPE-3 Phase 3 trial meeting primary and all secondary endpoints.
- Company expects to be eligible for a Priority Review Voucher upon potential approval.
- FDA has not identified any review issues in its response to Capricor at this time.

## SEC filing metadata
- accession: 0001104659-26-025657
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-03-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/0001104659-26-025657-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/capr-20260310x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-025657
- JSON: https://secwatch.observer/filing/0001104659-26-025657.json
- Plain text: https://secwatch.observer/filing/0001104659-26-025657.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.