---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-100071"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-08-24T13:25:30+00:00"
generated_at: "2026-08-24T13:26:14.195443+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA extends Capricor's Deramiocel PDUFA target date to Nov 22, 2026

## Summary
- FDA extended PDUFA target date for Deramiocel BLA from Aug 22, 2026 to Nov 22, 2026.
- Amendment includes 24-month open-label extension data from pivotal Phase 3 HOPE-3 study.
- Capricor requests refined indication focused on upper limb function, HOPE-3's primary endpoint.
- HOPE-3 met primary endpoint with statistically significant benefit in upper limb function.
- FDA accepted amendment citing significant unmet medical need in Duchenne muscular dystrophy.

## SEC filing metadata
- accession: 0001104659-26-100071
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-08-24T13:25:30+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/0001104659-26-100071-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-100071
- JSON: https://secwatch.observer/filing/0001104659-26-100071.json
- Plain text: https://secwatch.observer/filing/0001104659-26-100071.txt

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