pdufa.bio
HomeDecisionsMNKD 2026-05-29

MNKD FDA decision: May 29, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

MannKind Corporation, Afrezza (Technosphere Insulin) - (INHALE-1) · Pediatric type 1/2 diabetes.

Run-up into the decision (T-120 → T+5)

PDUFA 5/29/26$6.21$2.2812/12/25
Daily close, T-120 (12/12/25) through T+5. Run-up high $6.21 on 2/6/26, low $2.28 on 3/27/26 (T-120 to T-1). FDA decision 5/29/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-29
OutcomeApproved
Drug / candidateAfrezza (Technosphere Insulin) - (INHALE-1)
CompanyMannKind Corporation
120-day run-up (T-120→T-1)-36.3%

Questions

Was Afrezza (Technosphere Insulin) - (INHALE-1) approved by the FDA?

Yes. The FDA approved the application for Afrezza (Technosphere Insulin) - (INHALE-1) on May 29, 2026. The primary source is linked on this page.

Which company is behind Afrezza (Technosphere Insulin) - (INHALE-1)?

Afrezza (Technosphere Insulin) - (INHALE-1) is a MannKind Corporation (MNKD) program. The FDA decision came on May 29, 2026; the company's own announcement is linked on this page.

How did MNKD stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), MNKD moved -36.3%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.