MannKind Corporation has gained roughly 20% since 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 on May 29, expands the drug's use beyond adults, where it was already approved. More than 350,000 children and adolescents in the US have diabetes and most need lifelong insulin therapy. The drug uses the company's Technosphere platform to deliver insulin via the lungs for rapid absorption, and the approval was based on the INHALE-1 trial plus two decades of additional safety and efficacy data. On June 23, MannKind also announced a grant from Breakthrough T1D to support the INHALE-1ST clinical study, which tests whether Afrezza can be used soon after a type 1 diabetes diagnosis in kids. Analysts' 12-month average price target suggests more than 54% upside from the current level.
MannKind CorpFDA approval of Afrezza for children expands market and drives stock gain.