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GSK FDA Decision Approved · 2025-12-11

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

Daily close, T-120 (6/26/25) through T+5. Run-up high $48.97 on 12/3/25, low $36.2 on 7/23/25 (T-120 to T-1). FDA decision 12/11/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-12-11

DrugBlujepa (gepotidacin)

IndicationUncomplicated urogenital gonorrhoea in patients 12 years of age and older

Outcome✓ Approvedprimary-sourced

Decision-day move+1.0%

T-120 run-up (low→high)+30.0% ($37.71→$48.97)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA218230, action date 2025-12-11

Market-cap tierLarge

Cohort decision-day move (history)1.0% median (n=895)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Blujepa (gepotidacin) approved by the FDA?

Yes. The FDA approved the application for Blujepa (gepotidacin) on December 11, 2025, per the FDA's own record. The primary source is linked on this page.

What was Blujepa (gepotidacin) under FDA review for?

The application covered Uncomplicated urogenital gonorrhoea in patients 12 years of age and older. The FDA approved the application on December 11, 2025.

How did GSK stock react to the FDA decision?

On the decision day GSK moved +1.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.