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Mesoblast Advances Paediatric Treatment with RYONCIL in U.S.

Mar 31, 2025

Mesoblast Limited (ASX: MSB) has marked a significant milestone with its RYONCIL (remestemcel-L) therapy, becoming the first FDA-approved mesenchymal stromal cell (MSC) treatment for any indication. The U.S. Centers for Medicare & Medicaid Services (CMS) has entered into a National Drug Rebate Agreement with Mesoblast, enabling nationwide coverage for paediatric patients suffering from steroid-refractory acute graft versus host disease (SR-aGvHD).

Treatment has now begun for the first three children under this initiative. RYONCIL is an off-the-shelf MSC therapy designed to combat severe inflammation and is administered over four weeks. Mesoblast, headquartered in Melbourne with operations in the U.S. and Singapore, is expanding its cell therapy pipeline across various conditions including adult SR-aGvHD, inflammatory bowel disease, heart failure, and chronic back pain. With a robust patent portfolio and global partnerships, the company is poised for commercial growth and broader therapeutic impact.

 

 

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