The Bio Report

Small molecule drugs and monoclonal antibodies often fall short at addressing severe inflammatory and immune‑mediated diseases. Mesoblast has spent more than 15 years industrializing mesenchymal stromal cell therapies to treat these conditions. In late 2024, it won U.S. Food and Drug Administration approval for Ryoncil, the first mesenchymal stromal cell therapy approved in the United States. Ryoncil is approved to treat steroid‑refractory acute graft‑versus‑host disease in pediatric patients 2 months of age and older. Mesoblast founder and CEO Silviu Itescu discusses how this class of therapy can help dampen cytokine‑driven hyperinflammation, how the company is extending its platform into other high‑burden conditions, and what distinguishes its second‑generation cell therapy now in development from its first.