The FDA approved Tregzi (Orca-T) on June 30, 2026, for high-risk blood cancer patients undergoing stem cell transplants.
Tregzi uses precision-engineered regulatory T cells to significantly reduce the risk of chronic graft-versus-host disease (GVHD).
Clinical trials showed 78% cGVHD-free survival at one year, compared to 38.4% with standard transplant procedures.
The therapy features a rapid 72-hour vein-to-vein manufacturing window, facilitating efficient delivery to specialized transplant centers.