Capricor Sues Nippon Shinyaku and NS Pharma Over Pricing Flaw and Launch Delays for Deramiocel DMD Therapy
Capricor Therapeutics filed a lawsuit on May 7-8, 2026, against Nippon Shinyaku and NS Pharma in New Jersey state court.
The suit alleges a 'fatal flaw' in the 2022 distribution agreement's pricing formula, making deramiocel economically unviable for Medicare, Medicaid, and private insurers due to inadequate reimbursement.
Capricor claims NS Pharma failed to prepare for commercial launch and refused to fix the pricing issue despite good-faith efforts.
Capricor seeks to rescind the agreement and obtain an injunction to distribute deramiocel directly in the US.
Deramiocel, an investigational cell therapy for DMD skeletal and cardiac manifestations, has a pending FDA decision by August 22, 2026, after priority review.
Nippon Shinyaku's shares dropped 15% following the news.