FDA Approves Orca Bio’s TREGZI For Allogeneic Hematopoietic Transplants

On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI™ for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies.

TREGZI™ is manufactured individually for each patient using cells collected from a matched donor. The therapy combines hematopoietic stem and progenitor cells (HSPCs), regulatory T cells (Tregs), and conventional T cells (Tcons) to reconstitute the immune system.

The FDA granted approval based on data from Orca Bio’s Phase 3 Precision-T clinical trial, with 78% of patients receiving TREGZI™ seeing higher rates of GVHD-free survival, compared to 38% of patients who underwent conventional allogenic hematopoietic stem cell transplant (alloHSCT).

This is Orca Bio’s first regulatory approval.