---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-088667"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-07-30T20:05:11+00:00"
generated_at: "2026-07-30T20:07:07.072389+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA advisory panel votes 9-3 against Deramiocel effectiveness for DMD cardiomyopathy

## Summary
- FDA CTGT Advisory Committee voted 9-3 that evidence did not support Deramiocel's effectiveness for DMD cardiomyopathy; vote is non-binding.
- PDUFA target action date remains August 22, 2026; FDA will consider committee recommendation in BLA review.
- Committee's voting question addressed a narrower indication than Capricor proposed; no vote on overall benefit-risk.
- In separate discussion, committee gave directionally supportive feedback on upper limb function from HOPE-3 trial.
- CEO Linda Marbán expressed commitment to Deramiocel and confidence in HOPE-3 data; patients and families shared support.

## SEC filing metadata
- accession: 0001104659-26-088667
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-07-30T20:05:11+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926088667/0001104659-26-088667-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926088667/capr-20260729x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-088667
- JSON: https://secwatch.observer/filing/0001104659-26-088667.json
- Plain text: https://secwatch.observer/filing/0001104659-26-088667.txt

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