F2G and Shionogi reported positive Phase 3 outcomes for olorofim, strengthening the companies’ case for an oral treatment option for invasive aspergillosis. The data showed noninferiority versus intravenous Ambisome (amphotericin B) in patients with refractory aspergillosis or who were unsuitable for azole therapy. F2G said the primary noninferiority endpoint was met, with all-cause mortality at day 42 of 23.8% for olorofim and 24.3% for Ambisome. The Phase 3 readout is intended to support the companies’ next regulatory steps after a prior FDA complete response letter. The results also highlight a supply- and administration-oriented value proposition for patients and clinicians, aiming to reduce reliance on IV antifungals in difficult-to-treat fungal disease.