Home › FDA Decisions › ABBV 2026-02-20

ABBV FDA Decision Approved · 2026-02-20

Page updated October 4, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

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=837)

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 primary-sourced approved by the FDA?

Yes. The approval of the application for primary-sourced was announced on February 20, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. 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.