Orca Bio received a landmark FDA nod for Tregzi, becoming the first FDA-approved cell therapy built on regulatory T cells (Tregs). Clinical trial results showed a reduced risk of graft-versus-host disease, a key complication of allogeneic stem cell transplants used for certain blood cancers. The approval extends the cell-therapy toolbox beyond conventional CAR-T and other immune effector approaches by formalizing an immunoregulatory strategy using Tregs. Orca said the product is intended for a specific transplant setting consistent with the trial evidence.