MannKind Eyes Best Month Since 2022 as May 29 FDA Pediatric Afrezza Decision Looms
MNKD•FDA will decide by May 29 on inhaled insulin Afrezza for ages 4-17 following a 26-week Phase 3 Inhale-1 trial showing safety and efficacy. Shares are set for their biggest gain since 2022 as MannKind readies presentations on A1c results and patient satisfaction at next week’s ADA sessions.
1. Phase 3 Inhale-1 Trial Results
The 26-week open-label study evaluated Afrezza in patients aged 4 to 17, comparing inhaled insulin plus basal therapy against multiple daily injections combined with basal insulin, and showed comparable A1c reductions with a favorable safety profile.
2. Upcoming FDA PDUFA Decision
The FDA set a Prescription Drug User Fee Act target action date of May 29 for the pediatric approval of Afrezza, which would expand its current adult-only label and allow inhaled insulin therapy for type 1 and type 2 diabetes in children and adolescents.
3. ADA Scientific Sessions Presentations
MannKind will present additional data next week, including pediatric treatment satisfaction metrics, detailed A1c outcome analyses, inhaled insulin use with automated delivery systems, and exploratory findings on gestational diabetes applications.
4. Stock Performance
Shares have rallied into a potential best monthly gain since early 2022, driven by growing optimism around the FDA decision and the prospect of broader Afrezza adoption in younger patient populations.
