The FDA approved Orca Bio’s Tregzi, a personalized regulatory T-cell (Treg) therapy designed to reduce graft-versus-host disease complications after matched-donor allogeneic HSCT. The approval makes Tregzi the first cell therapy based on regulatory T cells. Orca said clinical results from its Phase III Precision-T trial showed reduced risk of chronic GVHD-related outcomes and related complications, supporting broader use in hematologic malignancies undergoing transplant. The therapy is intended to improve chronic GVHD-free survival while supporting immunologic and hematopoietic reconstitution. The approval is set to expand the cell-therapy category beyond conventional approaches used in HSCT and underscores regulators’ growing comfort with personalized, manufacturing-intensive cellular products.