Mesoblast (ASX:MSB) has announced that the FDA (Food and Drug Administration - US) has scheduled a Pre-License Inspection (PLI) of the company's remestemcel-L in the treatment of children with SR-aGVHD.
The FDA accepted Mesoblast's resubmission of the BLA for remestemcel-L in March this year and set a PDUFA goal date of August 2, 2023.
If approved, remestemcel-L will be the first allogeneic "off-the-shelf" cellular medicine in the US and the first therapy for children under 12 with SR-aGVHD - steroid-resistant or steroid-refractory acute graft-versus-host disease.
Mesoblast's share price is up 1% on the news.