Mesoblast Reports $13.2M Revenue from Ryoncil Launch in US Pediatric GVHD

Mesoblast Ltd has reported strong initial sales of Ryoncil®, the first FDA-approved mesenchymal stromal cell product in the U.S. for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children, generating $13.2 million in gross revenue in its first quarter post-launch. The company has successfully onboarded over 25 transplant centers and aims to complete onboarding across 45 priority centers, which cover about 80% of U.S. pediatric transplants, while coverage now extends to over 250 million U.S. lives through commercial and government payers, including mandatory Medicaid coverage effective July 1. Ryoncil® benefits from seven years of orphan-drug exclusivity and additional biologic and intellectual property protections that secure market exclusivity until 2036 and beyond, limiting competition from biosimilars. Mesoblast is also advancing efforts to expand Ryoncil®’s label to include adults with SR-aGvHD through a pivotal trial in collaboration with the NIH-funded Bone Marrow Transplant Clinical Trials Network. Analysts generally rate Mesoblast as an outperform, with optimistic price targets, although some valuation models suggest downside risk, emphasizing the need for continued revenue growth and market expansion. The company maintains a strong cash position and provides comprehensive patient access programs to support treatment availability.