TuHURA Biosciences Says FDA Clears Phase 1b Trial of TBS-2025 in Acute Myeloid Leukemia

09:17 AM EDT, 09/14/2026 (MT Newswires) -- TuHURA Biosciences (HURA) said Monday that the US Food and Drug Administration has cleared its investigational new drug application for a phase 1b clinical study to evaluate TBS-2025 as a treatment for molecularly defined subsets of acute myeloid leukemia and other blood-related cancers. The company said the study will evaluate the safety and potential efficacy of TBS-2025 as a monotherapy in patients with relapsed/refractory mutNPM1 acute myeloid leukemia who have failed to respond to or relapsed after menin inhibitor therapy. Shares of the company were up 2.4% in Monday's premarket activity.