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Highlights

  • Mesoblast's products are exempt from U.S. tariffs due to U.S. Country of Origin status.
  • Ryoncil® is the only FDA-approved therapy for steroid-refractory acute graft versus host disease.
  • All products are manufactured using U.S. donors within the United States.

Mesoblast (Nasdaq: MESO) has confirmed that its allogeneic cellular products, including Ryoncil® and Revascor®, will be exempt from U.S. tariffs. This exemption is made possible because the company’s products are designated as “U.S. Country of Origin” products. All products are manufactured using U.S. donors and produced within the United States, which aligns with the requirements for tariff exemption.

Ryoncil® stands out as the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication. It is specifically approved for treating pediatric patients aged 2 months and older who are suffering from steroid-refractory acute graft versus host disease (SR-aGvHD), a condition that has a high mortality rate if not treated effectively. This approval reflects Ryoncil’s significant potential in addressing critical healthcare needs in pediatric populations.

In addition to Ryoncil®, Mesoblast’s other product, Revascor®, is part of the company’s portfolio of allogeneic cellular therapies, designed to target complex conditions such as heart failure. The tariff exemption on these products ensures a more favorable economic environment for their distribution within the U.S., potentially reducing costs and increasing access.

The company’s manufacturing model, which relies on U.S. donors and production facilities, places it in a competitive position in terms of both regulatory compliance and supply chain efficiency. As healthcare continues to focus on innovative treatments, Mesoblast’s work in cellular therapy and its exemption from U.S. tariffs could enhance its operational flexibility moving forward.

This development allows Mesoblast to maintain a more stable pricing structure for its U.S. market while continuing to provide critical treatments to patients with severe, often life-threatening conditions.