The FDA has approved Orca Bio’s Treg-based cell therapy, branded Tregzi, for matched-donor allogeneic hematopoietic stem cell transplantation (HSCT) to reduce the risk of chronic graft-versus-host disease (GVHD). The approval is backed by results from Orca’s Precision-T Phase 3 trial, supporting improved chronic GVHD-free survival. Tregzi is described as a first-of-its-kind, personalized cell therapy built around regulatory T cells (Tregs). Orca also said it is moving patients into a new risk-benefit profile for transplant settings where GVHD complications have long limited outcomes. For biotech and transplant centers, the decision signals regulatory acceptance of Treg-centric cellular approaches beyond standard immunosuppression and post-transplant management algorithms.