Capricor Therapeutics Inc. (NASDAQ: CAPR) filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma Inc. over their distribution agreement for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy.

The biotechnology company claims NS Pharma failed to adequately prepare for the commercial launch of Deramiocel and that a pricing mechanism in their agreement would prevent patients covered by Medicare, Medicaid, or private insurance from accessing the therapy. Capricor seeks to rescind the distribution agreement.

"I have spent nearly two decades building Capricor with one goal in mind: making Deramiocel available to treat these boys," said Dr. Linda Marbán, CEO of Capricor. "There is no version of this case in which I am willing to watch NS Pharma's inaction take that away from them."

Duchenne muscular dystrophy affects approximately 15,000 people in the United States, primarily boys and young men. The genetic disorder is progressive and fatal.

Capricor filed a motion for preliminary injunction seeking to preserve its ability to distribute Deramiocel to patients pending FDA approval. The Food and Drug Administration granted Deramiocel Priority Review with a target PDUFA action date of August 22, 2026.

The company stated it attempted to resolve the pricing issues through good faith negotiations, but NS Pharma refused to compromise. Capricor is developing commercial readiness plans for a potential launch if the FDA approves the therapy.

The lawsuit details are based on statements from Capricor's press release announcing the legal action.