FDA Approves Mesoblast's Cell Therapy To Treat Steroid-refractory Acute Graft-versus-host Disease

(RTTNews) - The U.S. Food and Drug Administration approved Mesoblast Limited's (MESO, MSB.AX) Ryoncil or remestemcel-L-rknd, an allogeneic (donor) bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older, including adolescents and teenagers.

MESO closed Wednesday's trading at $12.25, down $0.26 or 2.08%. But in the after-hours, the stock gained $4.12 or 33.63%.

Ryoncil will be available in the United States at transplant centers and other treating hospitals, Mesoblast said in a statement.

Ryoncil is the first FDA-approved mesenchymal stromal cell (MSC) therapy. It contains MSCs, which are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isolated from the bone marrow of healthy adult human donors.

Steroid-refractory acute graft-versus-host disease is a serious and life-threatening condition that can occur as a complication of allogeneic hematopoietic (blood) stem cell transplantation (allo-HSCT). In allo-HSCT, a patient receives hematopoietic stem cells from a healthy donor to replace their own stem cells and form new blood cells, a procedure often done as part of treatment for certain types of blood cancers, blood disorders or immune system disorders.

Annually in the United States approximately 10,000 patients undergo an allogeneic bone marrow transplant, 1,500 of whom are children. Approximately 50% develop aGvHD and almost half of those do not respond to steroids, the recognized first-line treatment.

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