05:53 AM EDT, 03/26/2024 (MT Newswires) -- Mesoblast (MESO) said late Monday the US Food and Drug Administration has indicated that the available clinical data from a phase 3 study appears to be adequate to support the submission of a proposed biologics license application for remestemcel-L.

Remestemcel-L is intended for treatment of children with steroid-refractory acute graft versus host disease, which is a complication of allogeneic hematopoietic stem cell transplantation.

Mesoblast said it plans to file a resubmission that addresses the FDA's concerns in Q2.

Shares of the company were up more than 22% in Tuesday premarket activity.

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