Regeneron Pharmaceuticals Inc. and Sanofi have announced positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 trial evaluating Dupixent® (dupilumab) for the investigational treatment of allergic fungal rhinosinusitis (AFRS) in adults and children aged 6 years and older. The trial met all primary and secondary endpoints, demonstrating significant improvements in sinus opacification, nasal congestion, and nasal polyps compared to placebo. Results from this study were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2025 Annual Scientific Meeting. The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Dupixent in AFRS for Priority Review, with a target action date of February 28, 2026. If approved, Dupixent would become the first medicine specifically indicated for AFRS and its ninth FDA-approved indication.