The U.S. Food and Drug Administration has granted approval to Mesoblast Limited (under the ticker symbols MESO and MSB.AX) for its Ryoncil, also known as remestemcel-L-rknd. This innovative therapy uses donor-derived mesenchymal stromal cells sourced from bone marrow and is indicated for pediatric patients, aged two months and older, suffering from steroid-refractory acute graft-versus-host disease (SR-aGVHD).
On Wednesday, Mesoblast's stock concluded trading at $12.25, experiencing a modest dip of $0.26 or 2.08%. However, post-market trading saw an impressive increase, with shares rising $4.12, marking a 33.63% gain.
According to Mesoblast's official statement, Ryoncil is slated for availability at transplant centers and other medical facilities across the United States.
This approval marks a milestone as Ryoncil becomes the first mesenchymal stromal cell (MSC) therapy to receive FDA approval. MSCs, capable of multiple physiological functions and differentiation into various cell types, are extracted from the bone marrow of healthy adult donors.
Steroid-refractory acute graft-versus-host disease is a significant and potentially life-threatening complication, occurring post allogeneic hematopoietic stem cell transplantation (allo-HSCT). In this procedure, patients replace their stem cells with those from healthy donors to regenerate blood cells, a treatment often essential for certain blood cancers, blood disorders, or immune system ailments.
Annually, approximately 10,000 U.S. patients undergo allogeneic bone marrow transplantation, with 1,500 being children. About half of these patients develop acute graft-versus-host disease (aGvHD), and nearly 50% of these do not respond to steroids, the standard initial treatment.
