11:02 AM EDT, 06/09/2025 (MT Newswires) -- TuHURA Biosciences ( HURA ) said Monday the US Food and Drug Administration has removed the manufacturing-related partial clinical hold on its phase 3 trial for its drug candidate IFx-2.0.

"The removal...allows TuHURA to begin the trial's initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0," said Chief Executive Officer James Bianco.

The trial will evaluate IFx-2.0 as an adjunctive therapy with Keytruda as a first-line treatment for advanced and metastatic Merkel cell carcinoma, the company said.

The resolution also triggered the payment to the company of an additional $2.23 million under its funding condition, it added.

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