MannKind Corporation (NASDAQ:MNKD) announced that the U.S. Food and Drug Administration has approved Afrezza, an inhaled insulin, for pediatric patients with diabetes ages 6 and older. This approval, revealed on May 29, 2026, marks the first alternative to mealtime injections for approximately 95% of children diagnosed with type 1 diabetes in over a century.
Under CEO Michael Castagna’s leadership, Afrezza will be made available at $35 for patients under 23, irrespective of insurance coverage. The launch targets the pediatric type 1 diabetes market, which includes around 360,000 children and young adults, and aims for revenue potential of $300 million to $500 million over time. Initial sales are expected to start in June 2026, with ongoing discussions about payer coverage.
The INHALE-1 clinical trial involved 230 participants and demonstrated Afrezza’s effective glucose control, offering significant benefits such as no increase in BMI and improved treatment satisfaction over traditional injectables. MannKind plans additional developments, including a new 2-unit cartridge and digital tracking tools.
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