14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial.
The Dutch company Xenikos announced today that the U.S. FDA has granted fast track designation to T-Guard, Xenikos' flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial with T-Guard.