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BAYRY FDA Decision Approved · 2025-10-24

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 (5/9/25) through T+5. Run-up high $8.7 on 10/1/25, low $6.24 on 5/20/25 (T-120 to T-1). FDA decision 10/24/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-10-24

DrugLynkuet (elinzanetant)

IndicationModerate to severe hot flashes due to menopause

Outcome✓ Approvedprimary-sourced

Decision-day move+0.8%

T-120 run-up (low→high)+14.0% ($7.25→$8.7)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA219469, action date 2025-10-24

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.

See the full 2026 PDUFA calendar →

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

Questions

Was Lynkuet (elinzanetant) approved by the FDA?

Yes. The FDA approved the application for Lynkuet (elinzanetant) on October 24, 2025, per the FDA's own record. The primary source is linked on this page.

What was Lynkuet (elinzanetant) under FDA review for?

The application covered Moderate to severe hot flashes due to menopause. The FDA approved the application on October 24, 2025.

How did BAYRY stock react to the FDA decision?

On the decision day BAYRY moved +0.8%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.