Sep. 9 at 3:52 AM
$MESO FDA Approval & Commercial Launch of Ryoncil®
• Mesoblast achieved a significant milestone in FY 2025 by obtaining FDA approval for Ryoncil® (remestemcel-L), the first MSC therapy cleared for steroid-refractory acute GvHD in pediatric patients.
• The product’s commercial debut saw strong uptake:
$11.3 million in net sales during the first quarter, contributing to a full fiscal year product revenue of
$17.2 million, up 191% year-over-year. 
• The company now covers over 250 million U.S. lives, has on-boarded 32 transplant centers, and holds orphan drug exclusivity through 2032 plus biologic exclusivity through 2036.