---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-006020"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2024-04-29T23:59:59+00:00"
generated_at: "2026-06-03T05:24:08.975820+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Capricor presents CAP-1002 DMD program update: FDA alignment on BLA path; HOPE-3 topline data Q4 2024

## Summary
- Enrollment complete in HOPE-3 Phase 3 Cohort A (N=61); topline 12-month data expected Q4 2024.
- FDA agreed HOPE-3 Cohort A is sufficient to support BLA; non-clinical comparability shown with two potency assays.
- San Diego facility to be used for commercial manufacturing upon potential approval; commercial planning underway with Nippon Shinyaku.
- Upcoming Type-C meeting to discuss pre-BLA meeting and rolling BLA submission schedule.
- Estimated U.S. DMD annual product revenue opportunity >$1.5B; target addressable patients ~7,500-10,000.

## SEC filing metadata
- accession: 0001558370-24-006020
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2024-04-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837024006020/0001558370-24-006020-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837024006020/capr-20240429x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-006020
- JSON: https://secwatch.observer/filing/0001558370-24-006020.json
- Plain text: https://secwatch.observer/filing/0001558370-24-006020.txt

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