India, June 9 -- TuHURA Biosciences, Inc. (HURA), a Phase 3 immune-oncology company, announced Monday that the U.S. Food and Drug Administration (FDA) has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0.
This will allow the company's Phase 3 trial to proceed as agreed to under the previously announced Special Protocol Assessment (SPA) Agreement with the FDA.
The Company's Phase 3 accelerated approval trial of IFx-2.0, will now be conducted under an SPA Agreement with the FDA later in June 2025.
The trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda compared to Keytruda p...