08:34 AM EDT, 07/23/2024 (MT Newswires) -- Mesoblast (MESO) said Tuesday the US Food and Drug Administration has accepted the company's resubmitted biologics license application for Ryoncil, or remestemcel-L, to treat children with steroid-refractory acute graft versus host disease.

The FDA considers the resubmission complete, with a decision expected by Jan. 7, 2025.

Mesoblast said it resubmitted the application on July 8 after addressing the remaining chemistry, manufacturing and control items.

Shares of the company rose over 12% in Tuesday premarket activity.

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