pdufa.bio
Home › Decisions › ABBV 2026-06-26

ABBV FDA decision: Jun 26, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

SKYRIZI (risankizumab-rzaa) was approved by the FDA; the approval was announced on June 26, 2026.

AbbVie Inc., SKYRIZI (risankizumab-rzaa).

Run-up into the decision (T-120 → T+5)

PDUFA 6/26/26$243.14$197.381/9/26
Daily close, T-120 (1/9/26) through T+5. Run-up high $243.14 on 6/25/26, low $197.38 on 4/29/26 (T-120 to T-1). FDA decision 6/26/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-26
OutcomeApproved
Drug / candidateSKYRIZI (risankizumab-rzaa)
CompanyAbbVie Inc.
120-day run-up (T-120→T-1)+6.0%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.