---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-087891"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-07-29T14:05:21+00:00"
generated_at: "2026-07-29T14:06:35.067695+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Capricor's HOPE-3 Deramiocel data published in The Lancet; LVEF p-value revised to 0.09; FDA BIMO inspection cited

## Summary
- HOPE-3 Phase 3 results published in The Lancet; primary endpoint met: 54% slowing of upper limb decline (PUL 2.0, p=0.03).
- LVEF secondary endpoint p-value revised to 0.09 (1.8 ppt difference) from previously reported 0.04 (2.4 ppt) under updated statistical model.
- FDA BIMO inspection (July 6-20) resulted in Form 483 observation on SOPs, documentation, vendor oversight; company says data integrity unaffected.
- Deramiocel BLA under FDA review with PDUFA target action date of August 22, 2026.
- Pre-specified cardiomyopathy subgroup showed nominally significant LVEF benefit (p=0.02, 2.8 ppt difference).

## SEC filing metadata
- accession: 0001104659-26-087891
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-07-29T14:05:21+00:00
- event_type: other_material
- 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/1133869/000110465926087891/0001104659-26-087891-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926087891/capr-20260729x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-087891
- JSON: https://secwatch.observer/filing/0001104659-26-087891.json
- Plain text: https://secwatch.observer/filing/0001104659-26-087891.txt

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