---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-002097"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2025-03-04T23:59:59+00:00"
generated_at: "2026-05-25T12:45:59.835889+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Capricor's BLA for deramiocel for DMD cardiomyopathy with Priority Review, PDUFA Aug 31, 2025

## Summary
- FDA accepted BLA for deramiocel (cell therapy) to treat Duchenne muscular dystrophy cardiomyopathy.
- Priority Review granted; PDUFA target date August 31, 2025.
- FDA has not identified any potential review issues at this time.
- If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.
- Supports Phase 2 HOPE-2 and OLE trials vs. natural history data from FDA-funded dataset.

## SEC filing metadata
- accession: 0001558370-25-002097
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2025-03-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837025002097/0001558370-25-002097-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837025002097/capr-20250304x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-002097
- JSON: https://secwatch.observer/filing/0001558370-25-002097.json
- Plain text: https://secwatch.observer/filing/0001558370-25-002097.txt

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