---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-057221"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T21:24:33.384416+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Capricor sues Nippon Shinyaku over failed Deramiocel launch preparations; seeks agreement rescission

## Summary
- Filing of complaint in NJ Superior Court alleges fundamental pricing flaw in distribution agreement making Deramiocel commercially unviable under Medicare.
- Distributor accused of failing to complete gross-to-net model, mock launch, or obtain required sub-distributor consents for Capricor's cell therapy.
- Pricing structure renders Deramiocel economically impracticable for Medicare, Medicaid, and private insurance patients, per complaint.
- Capricor seeks rescission of distribution agreement, declaratory judgment, and preliminary injunction ahead of PDUFA date of August 22, 2026.
- FDA Priority Review for Deramiocel remains on track; Capricor states it is building commercial readiness independently.

## SEC filing metadata
- accession: 0001104659-26-057221
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926057221/0001104659-26-057221-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926057221/capr-20260507x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-057221
- JSON: https://secwatch.observer/filing/0001104659-26-057221.json
- Plain text: https://secwatch.observer/filing/0001104659-26-057221.txt

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