Capricor Therapeutics Sues Nippon Shinyaku and NS Pharma Over Pricing Dispute on Duchenne Muscular Dystrophy Therapy Deramiocel
Capricor Therapeutics filed suit in New Jersey state court on May 8, 2026, accusing Nippon Shinyaku and its U.S. subsidiary NS Pharma of failing to execute marketing plans for deramiocel and refusing to correct a pricing formula flaw discovered in March 2025.
prnewswire.comU.S. subsidiary NS Pharma in a New Jersey state court on May 8, 2026. The complaint accuses the companies of failing to follow through on marketing plans for a Duchenne muscular dystrophy treatment and refusing to fix a pricing glitch discovered in their exclusive distribution agreement.
A key issue is a “fatal flaw” in a pricing formula that would make it “economically impracticable” for the therapy to reach patients covered by Medicare, Medicaid, and private insurers, according to the lawsuit. Health care providers would get reimbursed less than they would pay to cover the cost of acquiring and administering the medicine, which is called deramiocel.
Nippon Shinyaku and NS Pharma disclosed the pricing problem in March 2025.
U.S. buyer under the exclusive distribution agreement.
STAT reported the details of the lawsuit on May 8, 2026. Ed Silverman, a senior writer and Pharmalot columnist at STAT, wrote the article published that day. The publication noted that the lawsuit describes the flaw as rendering patient access unworkable across major insurance types.
The suit states that as the arrangement stands, providers would face losses on every administration of deramiocel. Capricor Therapeutics maintains the partners have not addressed the defect despite having months to do so since the March 2025 disclosure.
Key Facts
Story Timeline
3 events- 2026-05-08
Capricor Therapeutics files lawsuit in New Jersey state court against Nippon Shinyaku and NS Pharma
1 sourceStat - 2026-05-08
STAT publishes article detailing the lawsuit by Ed Silverman
1 sourceStat - 2025-03
Nippon Shinyaku and NS Pharma disclose the pricing problem to Capricor
1 sourceStat
Potential Impact
- 01
Financial losses for health care providers administering the therapy under current reimbursement structure
- 02
Potential delay in patient access to deramiocel for Duchenne muscular dystrophy if the pricing issue remains unresolved
- 03
Disruption of the exclusive U.S. distribution agreement between Capricor and NS Pharma
Transparency Panel
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