---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-000010"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2025-01-02T23:59:59+00:00"
generated_at: "2026-05-28T17:36:22.125370+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Capricor submits BLA for deramiocel to FDA for DMD cardiomyopathy; receives $10M milestone

## Summary
- BLA for deramiocel (cell therapy) submitted to FDA for DMD cardiomyopathy on Jan 2, 2025.
- Submission triggers $10M milestone payment from partner Nippon Shinyaku to Capricor.
- If approved, deramiocel would be first approved therapy for DMD cardiomyopathy.
- Priority review requested; if granted, review timeline reduced to ~6 months from acceptance.
- Deramiocel holds Orphan Drug, RMAT (US), ATMP (EU) designations; potential PRV if approved.

## SEC filing metadata
- accession: 0001558370-25-000010
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2025-01-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/0001558370-25-000010-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837025000010/capr-20250102x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-000010
- JSON: https://secwatch.observer/filing/0001558370-25-000010.json
- Plain text: https://secwatch.observer/filing/0001558370-25-000010.txt

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