04:25 AM EDT, 07/09/2024 (MT Newswires) -- Mesoblast (MESO) said late Monday it has resubmitted a biologics license application for approval of its experimental drug, Ryoncil, to treat children with steroid-refractory acute graft-versus-host disease.

The US Food and Drug Administration informed the company in late March that clinical data from a phase 3 study appeared to be adequate to support the submission, Mesoblast said.

The resubmission, once accepted, is expected to be reviewed for between two and six months from receipt, the company said.

Acute graft-versus-host disease is a complication of allogeneic hematopoietic stem cell transplantation.

Price: 7.87, Change: +0.14, Percent Change: +1.81