Capricor Therapeutics, Inc. (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary, NS Pharma, Inc., over the parties' U.S. distribution agreement for Deramiocel, Capricor's investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD).

DMD is a fatal genetic disorder affecting approximately 15,000 people in the United States, most of them boys and young men. 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.

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.