STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug

STAT PlusPharmalot Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug Lawsuit claims delays will prevent desperate patients from accessing the therapy if approved Manage alerts for this article Email this article Share this article By Ed SilvermanMay 8, 2026 Pharmalot Columnist, Senior Writer Ed Silverman[email protected]Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. Capricor Therapeutics accused Nippon Shinyaku and its U.S. subsidiary of failing to follow through on marketing plans for a Duchenne muscular dystrophy treatment, and refusing to fix a pricing glitch that was belatedly 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 a lawsuit filed in a New Jersey state court on Thursday. Nippon Shinyaku and NS Pharma, the subsidiary, disclosed the problem in March 2025.Advertisement Basically, the formula ties Medicare reimbursement to the price that Capricor would charge NS Pharma, since it would be the only U.S. buyer. But as it stands, the lawsuit indicated that 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. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, drug pricing, Pharmaceuticals, STAT+ Submit a correction requestReprints Ed Silverman Pharmalot Columnist, Senior Writer Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. Newsletter From the lab to the medicine chest, these are the must-read drug industry updates of the day Recommended Pharmalot May 8, 2026 STAT Plus: Up and down the ladder: The latest comings and goings Pharmalot May 8, 2026 STAT Plus: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more Advertisement Pharmalot May 7, 2026 STAT Plus: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more Pharmalot May 6, 2026 STAT Plus: Pharmalittle: We’re reading about a PhRMA ad campaign aimed at 340B, sales of Novo’s obesity pill, and more Pharmalot May 5, 2026 STAT Plus: Pharma’s reputation among patient groups rose last year, but concerns remain over access and pricing Subscriber Picks