Mesoblast Ltd. (NASDAQ:MESO) saw its stock surge 25% after reporting the first commercial sales for Ryoncil, its newly launched treatment for pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD). The therapy generated $13.2 million in gross revenue during its first quarter on the U.S. market.
Ryoncil, officially launched on March 28, 2025, is the first and only FDA-approved mesenchymal stromal cell therapy available in the United States. It treats children who fail to respond to steroids after bone marrow transplants—an urgent and underserved medical need.
Alongside product sales, Mesoblast reported $1.6 million in royalties from its Japanese partner for sales of TEMCELL HS Inj. The company ended the quarter with $162 million in cash as of June 30, reflecting a solid financial position to support ongoing commercialization and development efforts.
Mesoblast’s commercial rollout is gaining traction, with over 25 transplant centers onboarded since launch. The company expects to have all 45 priority centers—which handle around 80% of U.S. pediatric transplants—fully integrated by the end of this quarter.
Insurance coverage has also ramped up, now extending to more than 250 million Americans through both private and government plans. As of July 1, all 50 states offer mandatory Medicaid fee-for-service coverage for Ryoncil.
To improve access, Mesoblast has established the MyMesoblast patient hub, designed to support treatment navigation and affordability. The therapy also benefits from seven years of orphan drug exclusivity, securing market protection until 2032, with additional biologic exclusivity extending to December 2036, blocking biosimilar competition.
Looking ahead, the company plans to pursue label expansion into adult SR-aGvHD, and continues developing pipeline candidates for chronic heart failure and chronic low back pain.
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