litigation
confidence high
sentiment negative
materiality 0.85
Capricor sues Nippon Shinyaku over failed Deramiocel launch preparations; seeks agreement rescission
CAPRICOR THERAPEUTICS, INC.
- 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.