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Will RYONCIL® US sales exceed $100 million in first year post-approval?
2
Resolution / Starting Odds
Yes • 50%
No • 50%
Mesoblast financial reports and press releases
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FDA Approves RYONCIL® for Pediatric Graft-Versus-Host Disease Treatment on December 18, 2024, as First MSC Therapy
Dec 18, 2024, 10:23 PM
The U.S. Food and Drug Administration (FDA) has approved Remestemcel-L, marketed as RYONCIL®, for the treatment of pediatric steroid-refractory acute graft-versus-host disease (GVHD). This approval, announced on December 18, 2024, allows the use of this allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy for patients aged two months and older who are experiencing this serious complication following stem cell or bone marrow transplants. Mesoblast, the company behind the therapy, has now achieved a milestone as RYONCIL® becomes the first MSC therapy approved in the United States, a significant advancement in the treatment options available for this vulnerable patient population.
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