Capricor sues Nippon Shinyaku and NS Pharma over Deramiocel U.S. distribution agreement

Capricor Therapeutics, Inc. (Nasdaq: CAPR) has sued its U.S. distribution partner for Deramiocel, its cell therapy for Duchenne muscular dystrophy (DMD). The defendants are Nippon Shinyaku Co., Ltd. and its U.S. subsidiary, NS Pharma, Inc. Capricor filed a Complaint for Equitable Relief and an Application for Preliminary Injunction in the Superior Court of New Jersey, Chancery Division, Bergen County, on May 7, 2026. The company disclosed the suit in a Form 8-K under Items 7.01 and 8.01. Linda Marbán, Ph.D., its chief executive officer, signed the filing.

The allegations below are Capricor's. The 8-K contains no response from Nippon Shinyaku or NS Pharma, and it gives no docket number for the case.

What Capricor alleges

The suit concerns a Commercialization and Distribution Agreement dated January 24, 2022, which the 8-K calls the U.S. Distribution Agreement. Capricor alleges a fundamental pricing flaw in that agreement. Its press release says the pricing mechanism would keep patients covered by Medicare, Medicaid or private insurance from getting the therapy. The release says Capricor tried in good faith to fix the mechanism, and that NS Pharma refused to compromise.

Capricor also alleges that NS Pharma failed to prepare adequately for the commercial launch of Deramiocel in the United States, and that it otherwise materially breached the agreement. These are claims in the company's own complaint. The filing does not describe the pricing mechanism in any detail.

What the company asks the court to do

Capricor seeks rescission of the U.S. Distribution Agreement, which would cancel it. It also asks for a declaratory judgment that the company may distribute Deramiocel directly or through distributors other than NS. It seeks preliminary injunctive relief and other equitable remedies. A preliminary injunction is an order issued early in a case to keep the situation in place while the case continues.

The release says the complaint and the injunction motion are meant to preserve Capricor's ability to distribute Deramiocel to patients who need it, pending FDA approval.

The partner is also a shareholder

Nippon Shinyaku is more than a distributor. The annual report for 2025, filed March 17, 2026, describes it as the company's exclusive distributor for DMD in the United States and Japan, and it refers to a separate Japanese distribution agreement. The report also describes a September 2024 private placement in which Nippon Shinyaku bought 2,798,507 shares of Capricor common stock at $5.36 a share, for about $15.0 million.

That makes the dispute one between a partner that controls the U.S. route to market and holds a stake in the company, and the company trying to take that route back. The 8-K does not address the stake.

The regulatory clock

The release says the FDA has granted Deramiocel Priority Review, with a target action date of August 22, 2026, and that the review process and expected timing are unchanged. The annual report says the Biologics License Application for Deramiocel is under FDA review. It also says Capricor currently has no products approved for commercial sale and generates no revenue from product sales.

The release calls Deramiocel investigational and says it has not been approved for commercial use in any indication. It says Capricor is building commercial readiness for a launch if the FDA approves the therapy, on a distribution timeline it has not set out in the filing.

The release describes Deramiocel's clinical record as extensive, but neither the 8-K nor the release gives efficacy results. The suit asks a court to change who sells the drug while the agency's decision is still months away, and the filing does not say what happens to the launch if the court grants no relief before then.

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