Capricor Sues NS Pharma Over Duchenne Therapy Distribution Dispute

Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku and its U.S. subsidiary NS Pharma over a dispute tied to the future commercialisation of experimental Duchenne muscular dystrophy therapy Deramiocel.

According to Capricor, provisions within the companies’ U.S. distribution agreement could restrict patient access to the therapy if approved, particularly for patients covered by Medicare, Medicaid and private insurance plans.

The company said it attempted to renegotiate the pricing structure with NS Pharma but alleged the parties were unable to reach a compromise. Capricor also claimed NS Pharma had not adequately prepared for the therapy’s commercial launch.

The lawsuit, alongside a motion for preliminary injunction, is aimed at preserving Capricor’s ability to distribute Deramiocel independently if the therapy receives FDA approval.

Deramiocel is currently under Priority Review by the FDA, with a target PDUFA decision date of August 22, 2026. Capricor stated that the regulatory review timeline remains unchanged despite the legal proceedings.

The dispute arrives as Deramiocel continues to attract attention following positive Phase 3 HOPE-3 trial data announced earlier this year.