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Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges
On Wednesday, the FDA approved Mesoblast Limited’s (NASDAQ: MESO ) Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S .
Ryoncil is the only MSC therapy approved in the U.S. for any indication and the only therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents.
Ryoncil contains MSCs, 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 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 stem cells and form new blood cells.
This procedure is often performed as part of treatment for certain types of blood cancers, blood disorders, or immune system disorders.
Annually, in the U.S., 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.
In a single-arm multi-center Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatment with Ryoncil, a measure that predicts survival in aGVHD.
Study participants who had a partial or mixed response to treatment—meaning that there was improved condition in one organ with either no change (partial) or worsening condition (mixed) in another organ—received additional infusions once weekly for an additional four weeks.
Sixteen study participants (30%) had a complete response to treatment 28 days after receiving Ryoncil, while 22 participants (41%) had a partial response.
Ryoncil treatment was not discontinued or interrupted in any patient for any laboratory abnormality, and the full course was completed without interruption in more than 85% of patients.
Price Action: MESO stock is up 42.60% at $17.47 during the premarket session at last check Thursday.
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