Mesoblast: U.S.-made cell therapies exempt from import tariffs

Mesoblast Limited announced on September 26, 2025, that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and are designated as U.S. origin products. This designation means they are not subject to tariffs on imported branded or patented pharmaceutical products. The company emphasized that Ryoncil® (remestemcel-L), the only allogeneic mesenchymal stromal cell therapy approved by the U.S. FDA, is documented as a 'U.S. Country of Origin' product.

Ryoncil® is approved for pediatric patients aged 2 months and older for steroid-refractory acute graft versus host disease (SR-aGvHD). Mesoblast confirmed that all its products, including those for SR-aGvHD, chronic heart failure, chronic back pain, and other inflammatory indications, are manufactured at U.S. sites. The company maintains an extensive global intellectual property portfolio with over 1,000 granted patents or applications expected to provide commercial protection through at least 2041.