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GSK PDUFA Date: Tebipenem HBr (SPR994)

FDA decision (PDUFA) target 2026-06-18 · GSK plc American Depositary Shares (Each representing two) · Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP)

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 date2026-06-18
Drug / candidateTebipenem HBr (SPR994)
IndicationComplicated urinary tract infection (cUTI), including acute pyelonephritis (AP)
CompanyGSK plc American Depositary Shares (Each representing two)
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT06059846 · completed

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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 2026-06-18 for Tebipenem HBr (SPR994). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is GSK's drug Tebipenem HBr (SPR994)?
Tebipenem HBr (SPR994) is GSK plc American Depositary Shares (Each representing two)'s candidate under FDA review for Complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).
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.