• TuHURA Biosciences received FDA IND clearance for TBS-2025, a VISTA-inhibiting antibody, in molecularly defined subsets of AML.
• “Study may proceed” notice enables a Phase 1b trial in relapsed or refractory mutNPM1 AML following menin inhibitor failure.
• Trial will assess monotherapy safety, dose escalation, then dose optimization to select a biologically effective dose.
• Company may discuss accelerated approval pathway if dose-optimization data show encouraging response rates.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tuhura Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609140745PR_NEWS_USPR_____LA46240) on September 14, 2026, and is solely responsible for the information contained therein.