---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-078327"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-06-26T21:15:16+00:00"
generated_at: "2026-06-26T21:16:13.660571+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA Advisory Committee set for July 29 to review Capricor's Deramiocel BLA; PDUFA date Aug 22

## Summary
- FDA CTGTAC Advisory Committee meeting scheduled for July 29, 2026, to discuss Capricor's Deramiocel BLA for Duchenne muscular dystrophy.
- PDUFA target action date remains August 22, 2026; BLA on track.
- BLA supported by Phase 2 HOPE-2, HOPE-2 OLE, and Phase 3 HOPE-3 trials showing statistical significance on primary and secondary endpoints.
- CEO Linda Marbán expressed confidence in the totality of evidence and commitment to urgent needs of DMD community.

## SEC filing metadata
- accession: 0001104659-26-078327
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-06-26T21:15:16+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926078327/0001104659-26-078327-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926078327/capr-20260626x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-078327
- JSON: https://secwatch.observer/filing/0001104659-26-078327.json
- Plain text: https://secwatch.observer/filing/0001104659-26-078327.txt

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