Capricor Therapeutics has accused Nippon Shinyaku and its U.S. subsidiary, NS Pharma, of failing to fulfill marketing plans for a Duchenne muscular dystrophy treatment and refusing to address a pricing glitch in their exclusive distribution agreement.
A lawsuit filed in a New Jersey state court on Thursday highlights a “fatal flaw” in a pricing formula that would render the therapy “economically impracticable” for patients covered by Medicare, Medicaid, and private insurers. Nippon Shinyaku and NS Pharma disclosed the issue in March 2025.
The pricing formula ties Medicare reimbursement to the price Capricor charges NS Pharma, as NS Pharma is the sole U.S. buyer. However, the lawsuit states that healthcare providers would receive less reimbursement than the cost of acquiring and administering the drug, called deramiocel.
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