Mesoblast Confirms U.S. Tariff Exemption for Allogeneic Cellular Products, Including Ryoncil® and Revascor®

04 April 2025 | Friday | News

Global Leader in Allogeneic Cellular Medicines Highlights U.S. Origin Status of Products, Ensuring Compliance with Recent Government Tariff Announcements
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Mesoblast, global leader in allogeneic cellular medicines for inflammatory diseases, provided an update on the status of its products in relation to the U.S. Government’s announcement on tariffs for imported products. Mesoblast believes that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to the tariffs.

Mesoblast develops allogeneic products based on its proprietary remestemcel-L and rexlemestrocel-L mesenchymal lineage stromal and precursor cell platform technologies. Its allogeneic cellular products derived from these platforms are manufactured from U.S. donors in the U.S. and designated as U.S. origin products.

Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration (FDA) for any indication. Ryoncil® is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates. Ryoncil® is designated a ‘U.S. Country of Origin’ product as documented in the Company’s Biologic License Application (BLA), in line with US FDA and Customs regulatory guidance.

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