F2G and Shionogi released positive Phase 3 results for olorofim, an orally administered antifungal being developed with a potential regulatory rebound after a prior FDA complete response letter. The companies said olorofim achieved noninferiority versus intravenous Ambisome (amphotericin B) in patients with refractory aspergillosis or those unsuitable for azole therapy. The Phase 3 primary endpoint of noninferiority was met, including day-42 all-cause mortality of 23.8% for olorofim versus 24.3% for Ambisome. The data, if supported through regulatory review, position olorofim as the first new antifungal drug in more than two decades. F2G said it now has the dataset needed to prepare for an NDA resubmission, representing a key inflection point for a program that had been held back following FDA feedback three years earlier. The next milestone for the companies is regulatory alignment around submission content and review timelines, with particular attention to how oral dosing efficacy and safety are framed against standard-of-care IV options.