Mesoblast disclosed that in its Emergency Investigational New Drug program for steroid‑refractory acute graft‑versus‑host disease, 15% of the 53 patients who received Ryoncil as a third‑line therapy died before completing a full course, compared with only 2% of patients who received the drug as a second‑line therapy in the Phase 3 MSB‑GVHD001 trial.
The data were presented at the Tandem Meetings of the American Society for Transplantation and Cellular Therapy and the Center for Blood and Marrow Transplant Research in Salt Lake City, Utah, during the meetings held February 4‑7, 2026.
Mesoblast’s chief executive, Dr. Silviu Itescu, emphasized that “Treatment initiation as early as possible is essential in order to give Ryoncil® the best chance to save as many precious lives as possible. The Phase 3 trial in adults with SR‑aGvHD will position Ryoncil® as the earliest treatment regimen for severe disease after steroid resistance.” The company is preparing to launch a pivotal adult SR‑aGvHD trial in the first quarter of 2026, which could unlock a market roughly three times larger than the current pediatric indication.
The company’s data reinforce its strategy to expand Ryoncil’s label to adults, a population that includes patients who have failed the established therapy ruxolitinib. By demonstrating comparable survival rates in adults and underscoring the benefit of earlier intervention, Mesoblast aims to position Ryoncil as a first‑line option after steroid resistance.
In related financial context, Mesoblast secured a $125 million credit facility in January 2026 and reported net revenue of $30 million for the quarter ending December 2025, with gross sales of $35 million. These figures provide a backdrop for the company’s ongoing investment in clinical development and market expansion.
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