Orca Bio’s Tregzi (formerly Orca-T) received U.S. FDA approval as a personalized cell therapy for matched-donor allogeneic HSCT in adults with hematologic malignancies. The therapy is positioned to improve transplant outcomes by reducing chronic graft-versus-host disease-free survival risk, following results from the Phase 3 Precision-T trial. FDA’s approval makes Tregzi the first cell therapy based on regulatory T cells (Tregs) for this use, and Orca said it is indicated across multiple adult blood cancer populations undergoing specified myeloablative conditioning. The decision arrives as transplant programs seek lower complication rates without compromising immune reconstitution, a key differentiator for allogeneic approaches.