---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-012983"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2024-09-24T23:59:59+00:00"
generated_at: "2026-05-31T01:59:47.756551+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Capricor Therapeutics to file BLA for deramiocel in DMD cardiomyopathy; rolling submission in Oct 2024

## Summary
- Plans to file BLA for deramiocel to treat DMD cardiomyopathy based on existing cardiac and natural history data; rolling submission begins Oct 2024 with full submission by year-end 2024.
- BLA supported by Phase 2 HOPE-2 and HOPE-2 OLE data vs natural history from Vanderbilt and Cincinnati Children's.
- Will combine Cohorts A and B of Phase 3 HOPE-3 as a post-approval study; no unblinding of Cohort A as previously planned for Q4 2024.
- Deramiocel has FDA Orphan Drug, RMAT, and Rare Pediatric Disease designations (PRV eligible upon approval).
- No approved therapies for DMD cardiomyopathy; deramiocel targets leading cause of death in Duchenne.

## SEC filing metadata
- accession: 0001558370-24-012983
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2024-09-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837024012983/0001558370-24-012983-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837024012983/capr-20240924x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-012983
- JSON: https://secwatch.observer/filing/0001558370-24-012983.json
- Plain text: https://secwatch.observer/filing/0001558370-24-012983.txt

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