TAMPA, Fla., June 9, 2025 - TuHURA Biosciences, Inc. (NASDAQ:HURA), an innovative Phase 3 immune-oncology company, announced that the FDA has lifted the manufacturing-related partial clinical hold on its Phase 3 trial for IFx-2.0, aimed at treating advanced or metastatic Merkel cell carcinoma. This pivotal trial will now proceed under a Special Protocol Assessment Agreement with the FDA, evaluating IFx-2.0 alongside Keytruda® as a first-line treatment. The removal of the hold also unlocks the second tranche of funds from a $12.5 million PIPE financing, specifically providing TuHURA with an additional $2.23 million. This financial boost facilitates the initiation and activation of clinical sites across the United States, advancing TuHURA's mission to overcome resistance in cancer immunotherapy.
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