FDA Clears TuHURA's TBS-2025 VISTA Antibody for Phase 1b AML Trial
HURA has more than doubled off its 52-week low of $0.41 on light trading volume (0.3× avg).
Summary
TuHURA received FDA clearance to begin a Phase 1b study of TBS-2025, its VISTA-inhibiting antibody, in relapsed/refractory mutNPM1 AML patients who failed menin inhibitor therapy. This is the first VISTA-targeting mAb to reach this stage in AML, addressing a population with no approved treatments. The company plans to seek accelerated approval if dose-optimization data are encouraging. This milestone follows a period of tight cash management—$1.0M cash at June 30, with draws on a $50M credit facility—so the clinical advance is a key value driver. Next catalyst: initial safety data from the Phase 1b study, which will determine progression to dose optimization.
At the time of this announcement, HURA was trading at $2.05 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $130.6M. The 52-week trading range was $0.41 to $3.43. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: PR Newswire.