MannKind provides business updates, 2026 growth drivers

MannKind (MNKD) Corporation provided business updates and outlined anticipated growth drivers for 2026, including progress across its commercial programs and clinical development initiatives. Major Catalysts Driving 2026: Afrezza Inhalation Powder – FDA decision on Afrezza label update anticipated with a PDUFA target action date of January 23, 2026; FDA accepted for review the supplemental Biologics License Application for Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes with a PDUFA target action date of May 29, 2026. FUROSCI – Supplemental New Drug Application for FUROSCIX ReadyFlow Autoinjector accepted for review by U.S. Food and Drug Administration with a PDUFA target action date of July 26, 2026. Pipeline – Nintedanib DPI saw its first patient enrolled in December for the INFLO-1 Phase 1b study and anticipates first patient in for INFLO-2 Phase 2 in Q2 2026. Advancing Bumetanide DPI pre-clinical development