FDA Accepts MannKind's SBLA For Afrezza, Assigns PDUFA Target Action Date Of May 29, 2026

(RTTNews) - MannKind Corp. (MNKD), Monday announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application for Afrezza (insulin human) Inhalation Powder for the treatment of type 1 or type 2 diabetes in children and adults.

The application has been assigned a Prescription Drug User Fee Act or PDUFA target action date of May 29, 2026.

The approval is based on the Phase 3 INHALE-1 study data, which evaluated Afrezza in combination with basal insulin vs. multiple daily injections with basal insulin.

The full findings of the study will be shared at the International Society for Pediatric and Adolescent Diabetes in early November.

In the pre-market hours, MNKD is trading at $4.99, up 2.14 percent on the Nasdaq.