Mesoblast (MSB:ASX; MESO:Nasdaq) has secured a significant agreement with the U.S. Centers for Medicare & Medicaid Services (CMS) for its Ryoncil (remestemcel-L) therapy. The Medicaid National Drug Rebate Agreement (NDRA) ensures both inpatient and outpatient access to Ryoncil for approximately 40% of U.S. children covered by Medicaid who suffer from steroid-refractory acute graft versus host disease (SR-aGvHD). This agreement, effective July 1, 2025, allows U.S. states the option to immediately cover Ryoncil, marking a substantial step in providing access to this therapy for a vulnerable patient population. Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) therapy, targets pediatric patients aged two months and older with SR-aGvHD, a condition characterized by high mortality rates. The treatment involves intravenous infusions twice weekly for four weeks. This week marks the commencement of Ryoncil treatment for the first three children with SR-aGvHD. Mesoblast’s CEO, Dr. Silviu Itescu, hailed the agreement as a major commercial achievement, emphasizing the company’s commitment to making Ryoncil available to all children in need. Mesoblast’s proprietary technology platform focuses on allogeneic cellular medicines designed to combat severe inflammatory conditions. Their cell therapies release anti-inflammatory factors, modulating the immune system to reduce damaging inflammation. The company holds a robust intellectual property portfolio, with patents extending to at least 2041 in major markets, and operates manufacturing facilities in Australia, the United States, and Singapore. Mesoblast is also developing Ryoncil for SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, and rexlemestrocel-L for heart failure and chronic low back pain.
