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Home › FDA Decisions › BAYRY 2025-10-24

BAYRY FDA Decision Approved · 2025-10-24

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/24/25$8.7$6.245/9/25
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=835)

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 →

Questions

Was Lynkuet (elinzanetant) approved by the FDA?

Yes. The FDA approved the application for Lynkuet (elinzanetant) on October 24, 2025. 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.