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ABBV FDA Decision Approved · 2025-10-13

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/13/25$244.38$173.784/28/25
Daily close, T-120 (4/28/25) through T+5. Run-up high $244.38 on 10/1/25, low $173.78 on 4/28/25 (T-120 to T-1). FDA decision 10/13/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±3.8% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 22%). The stock closed -0.1% at the first close across the decision and +0.3% 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 date2025-10-13
DrugRINVOQ (upadacitinib)
IndicationAdults with moderately to severely active ulcerative colitis (UC) and moderately to severe
Outcome✓ Approvedprimary-sourced
Decision-day move-0.1%
T-120 run-up (low→high)+28.0% ($182.31→$244.38)
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.

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Questions

Was RINVOQ (upadacitinib) approved by the FDA?

Yes. The FDA approved the application for RINVOQ (upadacitinib) on October 13, 2025. The primary source is linked on this page.

What was RINVOQ (upadacitinib) under FDA review for?

The application covered Adults with moderately to severely active ulcerative colitis (UC) and moderately to severe. The FDA approved the application on October 13, 2025.

How did ABBV stock react to the FDA decision?

On the decision day ABBV moved -0.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.