F2G and Shionogi advanced an NDA resubmission effort for olorofim, positioning it for what could become the first new antifungal in more than 20 years. The companies said they now have the data needed to refile after the FDA previously issued a complete response letter. In Phase III results, orally administered olorofim met noninferiority versus IV Ambisome (amphotericin B) in patients with refractory aspergillosis or those unsuitable for azole therapy. The primary noninferiority endpoint included all-cause mortality at day 42, with rates of 23.8% for olorofim and 24.3% for Ambisome. The resubmission is a key milestone for antifungal development, where the limited number of late-stage programs has left clinicians with aging options and constrained choices in high-risk fungal disease. If the FDA clears olorofim, it would broaden oral antifungal coverage in settings that historically required IV treatment.