LegalMay 7, 2026, 04:44 PM
Capricor Sues NS Pharma Over Deramiocel Distribution Agreement
AI Summary
Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary, NS Pharma, alleging a fundamental pricing flaw in their 2022 Commercialization and Distribution Agreement for Deramiocel. The lawsuit claims NS Pharma failed to adequately prepare for the commercial launch of Deramiocel for Duchenne muscular dystrophy (DMD) and materially breached the agreement. Capricor seeks rescission of the agreement, declaratory judgment for direct distribution, and preliminary injunctive relief to ensure patient access.
Key Highlights
- Capricor Therapeutics filed a lawsuit against Nippon Shinyaku Co., Ltd. and NS Pharma in New Jersey Superior Court.
- The lawsuit alleges a fundamental pricing flaw in the 2022 U.S. Distribution Agreement for Deramiocel.
- Capricor claims NS Pharma failed to adequately prepare for the commercial launch of Deramiocel.
- Capricor seeks rescission of the distribution agreement and the right to distribute Deramiocel directly.
- The pricing flaw is linked to Medicare reimbursement, making Deramiocel's distribution economically unviable.
- Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy (DMD).
- The FDA has granted Deramiocel Priority Review with a target PDUFA action date of August 22, 2026.