TuHURA gets FDA go-ahead for leukaemia antibody trial while cash stands at $1.9m

TuHURA Biosciences has won US regulatory permission to take its antibody TBS-2025 into patients, though the company's thin cash position, rather than the clearance alone, will shape how quickly it can use it. At the close of the third quarter it held $1.9 million, and it said its operations are being financed through a loan facility from its largest shareholder.

The company announced on 13 November 2026 that the Food and Drug Administration had cleared its investigational new drug application. TBS-2025 targets VISTA and will be studied in a Phase 1b trial in patients with relapsed or refractory acute myeloid leukaemia whose tumours carry a mutant NPM1 gene. The disclosure did not include the trial's design, enrolment size or start date.

The news came alongside TuHURA's third-quarter update, which also offered an early look at IFx-2.0 given with Keytruda in metastatic Merkel cell carcinoma. In that open-label study, the first three patients treated all showed responses. With so few patients and no control arm, the result is only a preliminary signal.

For context, an IND clearance only permits a sponsor to start human testing in the US. It says nothing about whether a drug is safe or effective. Beyond the cash balance, the company did not provide other third-quarter financial figures in the material reviewed.