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GSK PDUFA Date: Tebipenem pivoxil

FDA decision (PDUFA) target 2026-06-30 · GSK plc American Depositary Shares (Each representing two) · cUTI

GSK run-up into the PDUFA (last ~120 days)

$61.18$49
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-30
Drug / candidateTebipenem pivoxil
IndicationcUTI
CompanyGSK plc American Depositary Shares (Each representing two)
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.gov—

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FAQ

When is the GSK PDUFA date?
The FDA PDUFA target date for GSK (GSK plc American Depositary Shares (Each representing two)) is 2026-06-30 for Tebipenem pivoxil. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is GSK's drug Tebipenem pivoxil?
Tebipenem pivoxil is GSK plc American Depositary Shares (Each representing two)'s candidate under FDA review for cUTI.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.