Home › FDA Decisions › ABBV 2026-02-20

ABBV FDA Decision Approved · 2026-02-20

Updated September 23, 2026·next FDA decision on the calendar

Price into the decision (T-120)

Daily close, T-120 (9/5/25) through T+5. Run-up high $244.38 on 10/8/25, low $207.92 on 9/5/25 (T-120 to T-1). FDA decision 2/20/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-20

Outcome✓ Approvedprimary-sourced

Decision-day move+0.2%

T-120 run-up (low→high)+2.0% ($211.96→$236.28)

ValidationVerified 2026-08-12: SEC filing 0001104659-26-020643 of 2026-02-26 containing 'approval of'

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 primary-sourced approved by the FDA?

Yes. The FDA approved the application for primary-sourced on February 20, 2026. The primary source is linked on this page.

How did ABBV stock react to the FDA decision?

On the decision day ABBV moved +0.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.