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ABBV FDA Decision Approved · 2025-05-14

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 5/14/25$216.66$166.2811/27/24
Daily close, T-120 (11/27/24) through T+5. Run-up high $216.66 on 3/11/25, low $166.28 on 11/27/24 (T-120 to T-1). FDA decision 5/14/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 30, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.3% through May 16, 2025 (the first listed expiry after the decision; ATM implied volatility 26%). The stock closed -5.6% at the first close across the decision and -1.7% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-05-14
DrugEMRELIS (Telisotuzumab vedotin (Teliso-V)) - (LUMINOSITY)
IndicationNonsquamous non-small cell lung cancer (NSCLC)
Outcome✓ Approvedprimary-sourced
Decision-day move-5.6%
T-120 run-up (low→high)+24.0% ($169.2→$216.66)
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 EMRELIS (Telisotuzumab vedotin (Teliso-V)) - (LUMINOSITY) approved by the FDA?

Yes. The FDA approved the application for EMRELIS (Telisotuzumab vedotin (Teliso-V)) - (LUMINOSITY) on May 14, 2025. The primary source is linked on this page.

What was EMRELIS (Telisotuzumab vedotin (Teliso-V)) - (LUMINOSITY) under FDA review for?

The application covered Nonsquamous non-small cell lung cancer (NSCLC). The FDA approved the application on May 14, 2025.

How did ABBV stock react to the FDA decision?

On the decision day ABBV moved -5.6%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.