---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-016149"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2023-09-29T23:59:59+00:00"
generated_at: "2026-06-10T06:47:36.395198+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Capricor announces positive FDA Type-B meeting confirming Phase 3 path to BLA for CAP-1002 in DMD

## Summary
- FDA aligned on HOPE-3 trial design; key endpoints unchanged; BLA submission targeted for 2025.
- HOPE-3 enrollment ~90% complete (52 of ~58 patients dosed); interim analysis expected Q4 2023.
- Topline data for HOPE-3 expected Q4 2024; BLA supported by product from Los Angeles site.
- San Diego site work continues for potential commercial demand; CAP-1002 holds Orphan Drug and RMAT designations.
- Company eligible for Priority Review Voucher if CAP-1002 receives FDA approval for DMD.

## SEC filing metadata
- accession: 0001558370-23-016149
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2023-09-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837023016149/0001558370-23-016149-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837023016149/capr-20230929x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-016149
- JSON: https://secwatch.observer/filing/0001558370-23-016149.json
- Plain text: https://secwatch.observer/filing/0001558370-23-016149.txt

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