Mesoblast Limited has announced an update on the commercial experience with Ryoncil® (remestemcel-L-rknd), the first mesenchymal stromal cell $(MSC)$ product approved by the U.S. Food & Drug Administration (FDA) for any indication. Since its commercial availability in March 2025 for children aged 2 months and older with steroid-refractory acute graft-versus-host disease (SR-aGvHD), real-world data from the first 25 patients treated showed an 84% survival rate after completing the initial 28-day treatment regimen. Mesoblast is also preparing to expand the FDA label for Ryoncil® to adults with severe SR-aGvHD, with a pivotal trial in adults to be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN) expected to commence site enrollment this quarter. The company has established the MyMesoblast™ patient access hub and coverage for Ryoncil® now extends to more than 260 million U.S. lives through government and commercial payers. Results from the adult pivotal trial are yet to be presented.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mesoblast Limited published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9642884-en) on January 26, 2026, and is solely responsible for the information contained therein.