I'm LongbridgeAI, I can summarize articles.Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku and NS Pharma, claiming that their distribution agreement for the Duchenne muscular dystrophy treatment Deramiocel could limit patient access due to pricing issues. The company alleges that NS Pharma has not adequately prepared for the therapy's launch and has refused to revise the pricing structure. Despite the legal dispute, the FDA review timeline for Deramiocel remains unchanged, with a target action date of August 22, 2026. Capricor's shares fell 11.61% in premarket trading following the news.
Capricor Therapeutics Inc. (NASDAQ:CAPR) on Thursday filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma, Inc., alleging that flaws in the companies' U.S. distribution agreement for experimental Duchenne muscular dystrophy treatment Deramiocel could limit patient access to the therapy.
The biotechnology company said the dispute centers on pricing terms in the commercialization and distribution agreement tied to Deramiocel, an investigational cell therapy currently under FDA review for Duchenne muscular dystrophy (DMD).
Capricor Raises Concerns About Patient Access
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.
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The company said it attempted to work with NS Pharma to revise the pricing mechanism but claimed the Japanese drugmaker and its U.S. unit refused to compromise.
Capricor also alleged that NS Pharma failed to sufficiently prepare for the therapy's commercial launch.
Capricor said the lawsuit and a related motion for preliminary injunction are intended to preserve the company's ability to distribute Deramiocel if the therapy receives FDA approval.
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.
FDA Review Timeline Remains Unchanged
The company said 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 U.S. Food and Drug Administration (FDA), with a target PDUFA action date of August 22, 2026.
Capricor said the FDA review timeline remains unchanged despite the legal dispute.
In March, the company said the Phase 3 HOPE-3 trial met its primary endpoint and a key secondary cardiac endpoint, while 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.
CAPR Price Action: Capricor Therapeutics shares were down 11.61% at $30.00 during premarket trading on Friday, according to Benzinga Pro. Over the past month, CAPR has declined about 8.7% versus a 8.2% rise in the S&P 500 and is up roughly 3% year-to-date compared to the index's 6.7% gain.
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