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Biotech Stocks Facing FDA Decision In May 2026

MannKind
MannKind

The FDA is scheduled to announce its decision on MannKind Corp.'s (MNKD) supplemental Biologics License Application for Afrezza in pediatrics on May 29, 2026.

Afrezza is a rapid-acting inhaled insulin indicated to improve glycemic control and was approved for use in adult patients aged 18 years and older with diabetes mellitus in June 2014.

If approved for the proposed expanded use, Afrezza would be the first needle-free insulin option for pediatric patients.

Afrezza consists of single-use plastic cartridges filled with a white powder containing insulin (human), which is administered via oral inhalation using the Afrezza Inhaler only. The product generated $75 million in total sales in 2025, up 16% over the prior year.

MNKD closed Monday's trading at $2.63, down 2.59%.