CAPR · Capricor Therapeutics, Inc.

Capricor Therapeutics has initiated legal action in the Superior Court of New Jersey, Chancery Division, Bergen County, targeting a critical commercial partnership for its lead product candidate Deramiocel, an investigational cell therapy for Duchenne Muscular Dystrophy (DMD). The Complaint details a 'fundamental pricing flaw' in the Commercialization and Distribution Agreement dated January 24, 2022, with Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma, which allegedly interacts destructively with Medicare reimbursement frameworks, making distribution economically unviable for patients on Medicare, Medicaid, or private insurance. This flaw, described as a mutual mistake at signing, prevents either party from profitably manufacturing, selling, or administering the therapy. Beyond pricing, Capricor accuses NS of material breaches through inadequate launch preparations: failure to develop a gross-to-net revenue model, establish realistic wholesale pricing, conduct mock launch exercises, and secure Capricor's consent for subdistribution agreements. Despite over a year of good-faith efforts, including high-level meetings, NS refused compromises and instead demanded a 'PLD structure' that would cede full control of Deramiocel to them, culminating in Capricor's rejection on May 6, 2026. The lawsuit seeks rescission, declaratory rights for Capricor to distribute directly or via other partners, and immediate injunctive relief to avert irreparable harm to DMD patients, whose progressive disease inflicts irreversible muscle and cardiac damage with every delayed month. With Deramiocel's PDUFA date of August 22, 2026, approaching under Priority Review, this dispute threatens timely U.S. commercialization of a therapy shown in Phase 3 to slow skeletal deterioration by 54% and cardiac decline by 91% versus placebo. Capricor is proactively building its own distribution infrastructure, signaling readiness to bypass NS if successful. Investors face heightened uncertainty around partnership stability, potential milestone payments, and revenue timelines, though the equitable claims leverage the agreement's carve-out for urgent injunctive relief.