---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-009186"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2025-07-11T23:59:59+00:00"
generated_at: "2026-05-18T06:52:13.179214+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Capricor receives FDA Complete Response Letter for Deramiocel BLA; plans Q3 2025 resubmission with HOPE-3 data

## Summary
- FDA issued CRL stating BLA lacks substantial evidence of effectiveness; additional clinical data needed.
- Capricor plans to resubmit BLA in Q3 2025 with data from ongoing Phase 3 HOPE-3 trial (104 patients, topline Q3 2025).
- FDA confirmed review clock restarts upon resubmission; Type A meeting offered to discuss path forward.
- CRL referenced outstanding CMC items, but Capricor believes most were addressed; not reviewed due to CRL timing.
- Prior to CRL, BLA had Priority Review, successful pre-licensure inspection, and mid-cycle review completion.

## SEC filing metadata
- accession: 0001558370-25-009186
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2025-07-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/0001558370-25-009186-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000155837025009186/capr-20250711x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-009186
- JSON: https://secwatch.observer/filing/0001558370-25-009186.json
- Plain text: https://secwatch.observer/filing/0001558370-25-009186.txt

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