TuHURA announces FDA removed partial clinical hold on Phase 3 trial of IFx-2.0

TuHURA Biosciences (HURA) announced that the FDA has removed the manufacturing-related partial clinical hold on the Company’s Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA. “We are grateful for the collaborative interaction with the reviewers at the Office of Therapeutic Products and the Oncology Center of Excellence, including their quick response time and, importantly, their helpful recommendations going forward,” stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. “The removal of the partial clinical hold allows TuHURA to begin the trial’s initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0.”