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MNKD FDA decision — Jul 24, 2026

✓ APPROVED

FUROSCIX ReadyFlow (furosemide) Autoinjector approved as the first and only autoinjector delivering IV-equivalent diuretic therapy for edema in adults with chronic heart failure or chronic kidney disease, two days ahead of its PDUFA goal date (Jul 24 2026).

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

PDUFA 7/24/26$6.21$2.281/29/26
Daily close, T-120 (1/29/26) through T+0. Run-up high $6.21 on 2/3/26, low $2.28 on 3/25/26 (T-120 to T-1). FDA decision 7/24/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-07-24
OutcomeApproved
Drug / candidateFUROSCIX ReadyFlow Autoinjector (SCP-111)
IndicationEdema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD)
CompanyMannKind Corporation
Market-cap tierSmall
120-day run-up (T-120→T-1)-33.7%
Cohort decision-day move (history)±3% median

The PDUFA goal date was July 26, 2026. The FDA approved on July 24, 2026, two days early.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.

Primary source: MannKind Corporation investor release, July 24, 2026