Mesoblast (ASX:MSB) reports FDA approval for allogeneic cellular medicine

Mesoblast (ASX:MSB) has announced the FDA (US' Food and Drug Administration) has accepted the resubmission of Mesoblast's biologic license application for Remestemcel-L in children with steroid-refractory acute Graft Versus Host Disease.

Mesoblast says if approved by the goal date of August 2, Remestemcel-L would be the first allogeneic “off-the-shelf” cellular medicine in the US.

It also says it would be the first therapy for children under 12 years old with SR-aGVHD, offering potential survival benefits and improved outcomes.

Following the announcement, shares of Mesoblast went up 20%.