Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Afrezza (Technosphere Insulin) was approved by the FDA on May 29, 2026 for pediatric type 1/2 diabetes.
MannKind Corporation, Afrezza (Technosphere Insulin) · Pediatric type 1/2 diabetes.
Run-up into the decision (T-120 → T+5)
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.
Positioning before the decision
On May 20, 2026, 9 days before the decision date, at-the-money options priced a move of ±23.1% through Jun 5, 2026 (the first listed expiry after the decision; ATM implied volatility 140%). The stock closed +3.6% at the first close across the decision and -3.3% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Drug / candidateAfrezza (Technosphere Insulin) - (INHALE-1)
CompanyMannKind Corporation
120-day run-up (T-120→T-1)-36.3%
FDA record of the action: the FDA approved on May 29, 2026, per BLA 022472 SUPPL-29 (Drugs@FDA). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Afrezza (Technosphere Insulin) approved by the FDA?
Yes. The FDA approved the application for Afrezza (Technosphere Insulin) on May 29, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Afrezza (Technosphere Insulin)?
Afrezza (Technosphere Insulin) is a MannKind Corporation (MNKD) program. The FDA decision came on May 29, 2026; the FDA's own record of the decision 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.
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