TuHURA Biosciences Files New Drug Application for Evaluation of Antibody to Treat Subsets of AML

MT Newswires Live06-15

TuHURA Biosciences (HURA) said Monday it has filed an investigational new drug application with the US Food and Drug Administration for a study evaluating its TBS-2025 VISTA inhibiting antibody to treat molecularly defined subsets of acute myeloid leukemia and other blood-related cancers.

The company said the application is being filed following detailed feedback and guidance from the FDA on the previous IND filed in February.

The company said it is targeting starting the phase 1b/2 study in the second half of this year, depending on the FDA's written responses expected next month.

Shares of the company were up 3% in Monday's premarket activity.

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