The FDA approved Orca Bio’s personalized regulatory T-cell therapy, Tregzi, for matched-donor allogeneic hematopoietic stem cell transplantation (HSCT), with the goal of reducing chronic graft-versus-host disease and improving long-term outcomes for adults with hematologic malignancies. Orca said Tregzi is indicated in conjunction with myeloablative preparative regimens and is designed to improve hematopoietic and immunologic reconstitution while improving chronic GVHD-free survival. The approval follows submission of a BLA in 2025 based on data from the Phase III Precision-T trial. The decision places Orca Bio’s approach—previously known as Orca-T—into a growing category of living medicines built around regulatory cell phenotypes, and it provides a new clinical option for HSCT programs seeking to reduce the trade-offs associated with traditional transplant strategies. For transplant centers, the label expands the set of biologic-dependent workflows they will need to integrate—alongside existing conditioning protocols and post-transplant monitoring.