TuHURA Biosciences, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $126.2M
- Price
- $1.98
- % Change (Daily % change from the live per-ticker quote feed.)
- +1.54%
- Volume
- 140.4K
About
TuHURA Biosciences, Inc. is an immuno-oncology firm that has reached the critical Phase 3 registration stage of clinical development. The company is dedicated to pioneering innovative technologies designed to effectively combat the mechanisms by which cancers develop resistance to existing immunotherapy treatments. Its operations are based in Tampa, Florida.
Quick stats
Shares outstanding63.7M
Computed float41.8M
Float / shares65.5%
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001498382
Websitehttp://www.tuhurabio.com
AI Summary
AI-generated1/11
standardbullishclinical trial
TuHURA Biosciences Receives FDA "Study May Proceed" Notice and IND Clearance for the Evaluation of its TBS-2025 VISTA-Inhibiting Antibody in Molecularly Defined Subsets of AML and Other Blood-Related Cancers
The FDA has issued a 'Study May Proceed' notice and cleared TuHURA Biosciences' IND application for TBS-2025, a VISTA-inhibiting antibody, for molecularly defined subsets of acute myeloid leukemia and other blood-related cancers.
The clearance enables a Phase 1b study of TBS-2025 monotherapy in relapsed/refractory mutNPM1 AML patients who failed menin inhibitor therapy — a population with no approved treatments. If dose-optimization response rates are encouraging, TuHURA will discuss trial expansion with the FDA toward a potential accelerated approval.
CEO Dr. James Bianco called it a major milestone, noting TuHURA is the only known company to advance a VISTA-inhibiting mAb through the IND process into a Phase 1b AML study; preclinical murine models showed TBS-2025 improved survival.
TBS-2025 is TuHURA's second clinical pipeline asset behind IFx-2.0, which is in a Phase 3 registration trial as an adjunct to Keytruda in first-line advanced or metastatic Merkel Cell Carcinoma.
Red flags
- accelerated approval pathway is speculative and contingent on encouraging dose-optimization responses
- no human data yet for TBS-2025 — survival claims are from murine models only
- early-phase safety profile in humans unproven; trial must clear dose-escalation safety review with FDA before progressing