What does the FDA approval of Orca Bio’s Tregzi mean for matched donor stem cell transplants?

The FDA approved Orca Bio’s Tregzi on June 30, 2026, for matched donor hematopoietic stem cell transplantation in adults with hematologic malignancies. Based on the Precision‑T trial, Tregzi significantly reduced chronic graft‑versus‑host disease and improved survival outcomes, marking a milestone for allogeneic cell therapy and regulatory T‑cell–based approaches.