Mesoblast (ASX:MSB) received US Food and Drug Administration approval for mesenchymal stromal cell (MSC) therapy, Ryoncil, according to a Thursday filing with the Australian bourse.
Ryoncil is the only MSC therapy approved in the US for any indication and the only approved therapy for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children two months and older, the filing said.
SR-aGvHD is a stem cell transplant complication where a patient's disease doesn't respond to high-dose steroids.
Shares rose nearly 33% in morning trade Thursday and earlier reached their highest since December 2020.
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