Capricor sues Nippon Shinyaku and NS Pharma in New Jersey court over Deramiocel distribution flaws that could block Medicare/Medicaid access for DMD patients; FDA Priority Review PDUFA is Aug 22, 2026.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Capricor Therapeutics announced that it has filed a lawsuit against Nippon Shinyaku and its U.S. subsidiary NS Pharma over the companies’ U.S. commercialization and distribution agreement for deramiocel, an investigational cell therapy under review for Duchenne muscular dystrophy (DMD).
The complaint, filed on May 7, 2026, in New Jersey Superior Court, alleges that a pricing mechanism within the Commercialization and Distribution Agreement could prevent patients covered by Medicare, Medicaid, and private insurance from accessing deramiocel if approved. Capricor stated that it attempted to work with NS Pharma to revise the pricing structure, but the parties were unable to reach an agreement.
According to the company, NS Pharma also failed to adequately prepare for the potential commercial launch of deramiocel. Capricor said the legal action seeks equitable relief, including a preliminary injunction, to preserve a pathway for patient access pending potential U.S. Food and Drug Administration (FDA) approval. The company is also seeking to rescind the distribution agreement.
In a statement, Linda Marbán CEO of Capricor said the company remains focused on ensuring access to treatment for patients with DMD. She stated that Capricor has spent years advancing deramiocel with the goal of making the therapy available to affected patients and expressed concern that further delays could limit access to treatment for a progressive disease with irreversible muscle deterioration.
DMD is a rare, progressive X-linked genetic disorder caused by the absence of functional dystrophin, a structural protein required for muscle integrity. The disease primarily affects boys and leads to progressive degeneration of skeletal, respiratory, and cardiac muscles. According to Capricor, approximately 15,000 individuals in the United States are affected by the condition. Cardiomyopathy and heart failure remain major causes of mortality in DMD.
Deramiocel (CAP-1002) is an investigational allogeneic cell therapy composed of cardiosphere-derived cells (CDCs), a population of cardiac-derived cells with immunomodulatory and anti-fibrotic properties. The therapy is designed to preserve cardiac and skeletal muscle function by secreting extracellular vesicles known as exosomes, which may alter macrophage activity toward tissue repair and reduced inflammation.
According to Capricor, CDCs have been evaluated in more than 250 peer-reviewed scientific publications and administered to over 250 participants across clinical studies.
Deramiocel has received multiple regulatory designations, including Orphan Drug Designation from both the FDA and the European Medicines Agency for DMD. The therapy has also received Regenerative Medicine Advanced Therapy (RMAT) designation in the United States, Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA.
The FDA has granted Priority Review to deramiocel, with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. Capricor stated that the FDA review timeline remains unchanged despite the legal dispute.
The company also said it continues commercial readiness activities in preparation for a potential launch, with distribution planning intended to align with manufacturing capacity, patient demand, and provider and payer processes.
In response to the lawsuit, Nippon Shinyaku and NS Pharma stated that they disagree with Capricor’s claims and believe the allegations lack merit. The companies said they have been actively preparing for the potential commercialization of deramiocel and remain open to continued discussions regarding the agreement.
Reference
About the Writer
Karthik Teja Macharla, PharmD (LinkedIn) is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.