Mesoblast Limited on August 28, 2025, reported a landmark performance: its first U.S. Food and Drug Administration approval and successful commercial launch of Ryoncil® (remestemcel-L-rknd) for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients aged two months and older, marking the first U.S. approval of a mesenchymal stromal cell (MSC) therapy, according to the company.
Ryoncil® went on sale in the final quarter ending June 30, 2025, driving product revenues of US$17.2 million—a 191 percent increase year-on-year. The company said that the launch generated US$13.2 million in gross sales and US$11.3 million in net sales after adjustments.
Mesoblast reported net operating cash spend of US$50.0 million, reflecting a 3 percent rise—attributed in part to investments in building its commercial team and launch execution. Cash on hand as of June 30, 2025, stood at US$162 million.
The company also said that insurance coverage for Ryoncil® now spans over 250 million U.S. lives through both commercial and government payers, with mandatory fee-for-service Medicaid coverage effective in all U.S. states from July 1, 2025.
Mesoblast noted that it has onboarded 32 transplant centers so far, aiming to reach 45 centers—covering 80 percent of pediatric bone marrow transplants in the U.S.—by the end of the current quarter.
In summary, Mesoblast claims the FDA approval and commercial rollout of Ryoncil® underpin a “banner year,” with strong initial sales, expanding payer coverage, and growing market access through key transplant centers, backed by a solid cash position to support continued commercialization.
