Mesoblast’s Ryoncil® Awaits FDA Approval for SR-aGVHD

Mesoblast (MESO) has released an update.

Mesoblast Limited, a global leader in allogeneic cellular medicines, has announced that the FDA has accepted its Biologics License Application for Ryoncil®, aimed at treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). If approved, Ryoncil® would be the first ‘off-the-shelf’ cellular medicine in the US and the first cell therapy for children up to 18 years suffering from this condition. The FDA’s decision is expected by January 7, 2025, following promising clinical trial results showing significant improvement in survival rates.

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