Capricor Sues Nippon Shinyaku Over Distribution Agreement

Capricor Therapeutics (CAPR) announced that it has filed a lawsuit against Nippon Shinyaku (NPNKF) and its U.S. subsidiary, NS Pharma, over the parties' U.S. distribution agreement for Deramiocel, Capricor's investigational cell therapy for the treatment of Duchenne muscular dystrophy. "Deramiocel represents one of the most significant therapeutic advances for DMD, addressing both its skeletal and cardiac manifestations. NS Pharma's inaction may now jeopardize patients' access to this life-changing treatment," the company said. Capricor's complaint details how "a fundamental pricing flaw in the Commercialization and Distribution Agreement with NS Pharma will prevent patients covered by Medicare, Medicaid, or private insurance from accessing the therapy. Capricor has sought to work in good faith to fix this pricing mechanism with NS Pharma, but NS Pharma has refused to compromise. NS Pharma also has failed to adequately prepare for commercial launch of Deramiocel, and Capricor is now taking legal action to ensure there is a path for Deramiocel to reach the patients who urgently need it." The U.S. Food and Drug Administration has granted Deramiocel Priority Review, with a target PDUFA action date of August 22, 2026. The FDA review process and expected timing remain unchanged.