F2G and Shionogi reported positive Phase 3 results for olorofim, an orally administered antifungal, setting up the next regulatory step after an earlier FDA complete response letter. The companies said olorofim was noninferior to intravenous Ambisome (amphotericin B) in patients with refractory aspergillosis or those unsuitable for mainstay azole therapy. The trials’ primary noninferiority endpoint was met, with all-cause mortality at day 42 of 23.8% for olorofim versus 24.3% for Ambisome. F2G and Shionogi framed the dataset as sufficient for resubmission of an NDA for what the companies describe as the first novel antifungal in more than two decades. F2G said the companies plan to use the new package to prepare the NDA resubmission, aiming to restore momentum that was interrupted by the prior FDA rebuff. For acute-care infectious disease stakeholders, the readout matters because oral options can reduce IV dependence, support hospital throughput, and potentially expand treatment access for high-risk fungal infections.