Capricor Therapeutics Accuses Nippon Shinyaku of Mishandling Duchenne Drug Rollout

Capricor Therapeutics filed a lawsuit in New Jersey state court on May 8, 2026, accusing Nippon Shinyaku and NS Pharma of failing to follow through on marketing plans for deramiocel, a Duchenne muscular dystrophy treatment, and refusing to fix a pricing formula flaw disclosed in March 2025. The defect would make it economically impracticable for deramiocel to reach patients covered by Medicare, Medicaid, and private insurers, as providers would be reimbursed less than acquisition costs.

Capricor lawsuit against Nippon Shinyaku

• ▪Capricor Therapeutics accused Nippon Shinyaku and NS Pharma of failing to follow through on marketing plans for deramiocel, a Duchenne muscular dystrophy treatment.
• ▪Capricor Therapeutics accused Nippon Shinyaku and NS Pharma of refusing to fix a pricing glitch in their exclusive distribution agreement for deramiocel.
• ▪Capricor Therapeutics filed a lawsuit against Nippon Shinyaku and NS Pharma in a New Jersey state court on May 8, 2026.

Pricing formula flaw

• ▪Nippon Shinyaku and NS Pharma disclosed the pricing formula problem in March 2025.
• ▪The exclusive distribution agreement between Capricor Therapeutics and Nippon Shinyaku contains a fatal flaw in a pricing formula for deramiocel.
• ▪The pricing formula flaw would make it economically impracticable for deramiocel to reach patients covered by Medicare, Medicaid, and private insurers.

Medicare reimbursement issue

• ▪The pricing formula for deramiocel ties Medicare reimbursement to the price that Capricor Therapeutics would charge NS Pharma.
• ▪Under the current pricing formula for deramiocel, health care providers would get reimbursed less than they would pay to cover the cost of acquiring and administering the medicine.
• ▪NS Pharma would be the only U.S. buyer of deramiocel under the exclusive distribution agreement.

Perspective of Capricor Therapeutics

• ▪Capricor Therapeutics alleges that Nippon Shinyaku and NS Pharma are refusing to fix a pricing glitch that would block patient access to deramiocel.
• ▪Capricor Therapeutics alleges that Nippon Shinyaku and NS Pharma are deliberately slow-walking commercialization plans for deramiocel.

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