Capricor Therapeutics Inc. (Capricor (CAPR)) is taking its Japanese partner to court. On Thursday, the biotech company sued Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma, Inc., alleging that the companies' distribution agreement for the experimental Duchenne muscular dystrophy treatment Deramiocel is so flawed it could keep patients from getting the therapy.
The dispute centers on pricing terms in the commercialization and distribution agreement for Deramiocel, an investigational cell therapy currently under FDA review for Duchenne muscular dystrophy (DMD). According to an SEC filing, the agreement's pricing structure would prevent patients covered by Medicare, Medicaid, and private insurance plans from obtaining access to the treatment.
Capricor says it tried to work with NS Pharma to revise the pricing mechanism, but the Japanese drugmaker and its U.S. unit refused to compromise. Capricor also alleges that NS Pharma failed to adequately prepare for the therapy's commercial launch.
The lawsuit and a related motion for preliminary injunction are meant to preserve Capricor's ability to distribute Deramiocel if the therapy receives FDA approval, the company said.
CEO Linda Marbán Highlights Urgency For DMD Patients
Dr. Linda Marbán, CEO of Capricor, said she has spent nearly two decades working to bring Deramiocel to patients and criticized what she described as NS Pharma's inaction. The company is essentially arguing that the partnership meant to bring the drug to market is now the very thing that could block it.
FDA Review Timeline Remains Unchanged
Despite the legal drama, Capricor says it continues building commercial readiness plans for Deramiocel's potential launch, including manufacturing, provider coordination, and payer processes. Deramiocel has received Priority Review status from the FDA, with a target PDUFA action date of August 22, 2026. Capricor says the FDA review timeline remains unchanged.
In March, the company reported that the Phase 3 HOPE-3 trial met its primary endpoint and a key secondary cardiac endpoint. Newly presented late-breaking data showed reductions in myocardial fibrosis, improved left ventricular ejection fraction in patients with baseline cardiomyopathy, and about 83% slowing of disease progression on a functional eating task.
Investors are watching closely. Capricor shares were down 11.61% at $30.00 during premarket trading on Friday. Over the past month, CAPR has declined about 8.7% versus an 8.2% rise in the S&P 500, and is up roughly 3% year-to-date compared to the index's 6.7% gain.
