MannKind shares rise following FDA clearance for inhaled insulin Afrezza in patients aged 6 and older with diabetes.
MannKind Corporation (NASDAQ:MNKD) climbed roughly 20% after the FDA approved Afrezza, an inhaled insulin, for children and adolescents aged 6 and older with type 1 or type 2 diabetes. The approval, announced May 29, broadens the drug’s use beyond adults, where it was previously authorized.
The decision was supported by the INHALE-1 trial and two decades of safety data on inhaled insulin. Over 350,000 children and adolescents in the U.S. require lifelong insulin therapy, creating a significant market opportunity. Afrezza delivers insulin via the lungs using MannKind’s Technosphere platform for rapid absorption.
Analysts remain optimistic, with a 12-month average price target suggesting 54% upside from current levels. The company also secured a grant from Breakthrough T1D to study Afrezza’s use in newly diagnosed children.