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GSK FDA decision — Jun 18, 2026

✓ APPROVED

Utebzi (tebipenem pivoxil) approved — GSK-commercialized oral carbapenem for cUTI

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

PDUFA 6/18/26$61.18$47.651/1/26
Daily close, T-120 (1/1/26) through T+5. Run-up high $61.18 on 2/20/26, low $47.65 on 1/23/26 (T-120 to T-1). FDA decision 6/18/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-18
OutcomeApproved
Drug / candidateTebipenem HBr (SPR994) - (PIVOT-PO)
IndicationComplicated urinary tract infection (cUTI), including acute pyelonephritis (AP)
CompanyGSK plc
Market-cap tierLarge
120-day run-up (T-120→T-1)+6.5%
Cohort decision-day move (history)±1% median

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.