MannKind Corporation (NASDAQ:MNKD) shared business updates on January 8, outlining key growth drivers for 2026. Management reported that fiscal 2025 concluded with record fourth-quarter revenue surpassing $100 million.
The company anticipates significant regulatory progress in the coming months. The FDA is scheduled to provide updates to the Afrezza label on January 23. This revision is expected to simplify dosing for patients transitioning from injectable rapid-acting insulin, which could increase its use among adults with diabetes.
A supplemental Biologics License Application (sBLA) for Afrezza has a Prescription Drug User Fee Act (PDUFA) target date of May 29, 2026. Management stated that approval would make it the first needle-free insulin option for pediatric patients. Additionally, the FDA expects a supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow Autoinjector, with a PDUFA date of July 26, 2026. The company believes approval would enable delivery of an 80 mg/ml intravenous-equivalent diuretic dose in under ten seconds.
Wall Street analysts have expressed positive views on the stock. On January 13, Gregory Renza of Truist Financial reaffirmed a Buy rating. Earlier, on January 9, Brandon Folkes from H.C. Wainwright also reiterated a Buy rating and set a price target of $11.