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Company Plans to Commence New Pivotal, Randomized Phase 3 Study Evaluating T-Guard
® Versus Ruxolitinib in Patients with Grade III or IV Steroid-refractory Acute Graft-Versus-Host Disease in Second Half of 2021
Positive Results Expected to Support Both FDA and EMA Regulatory Submissions
NIJMEGEN, the Netherlands, July 19, 2021 (GLOBE NEWSWIRE) Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, today announced that it has reached agreement with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of its pivotal randomized Phase 3 clinical study (BMT CTN 2002) to evaluate T-Guard
Xenikos B.V.: Xenikos Announces T-Guard Phase 3 Clinical Update and Outlines 2021-2022 Corporate Objectives
Company Plans to Commence New Pivotal, Randomized Phase 3 Study Evaluating T-Guard Versus Ruxolitinib in Patients with Grade III or IV Steroid-refractory Acute Graft-Versus-Host Disease in Second Half of 2021
Positive Results Expected to Support Both FDA and EMA Regulatory Submissions
NIJMEGEN, the Netherlands, July 19, 2021 (GLOBE NEWSWIRE) Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, today announced that it has reached agreement with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of its pivotal randomized Phase 3 clinical study (BMT CTN 2002) to evaluate T-Guard