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ABBV FDA decision: May 27, 2026

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

LINZESS (Iinaclotide) was approved by the FDA; the approval was announced on May 27, 2026.

AbbVie Inc., LINZESS (Iinaclotide).

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

PDUFA 5/27/26$236.19$197.3812/10/25
Daily close, T-120 (12/10/25) through T+5. Run-up high $236.19 on 3/6/26, low $197.38 on 4/28/26 (T-120 to T-1). FDA decision 5/27/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-27
OutcomeApproved
Drug / candidateLINZESS (Iinaclotide)
CompanyAbbVie Inc.
120-day run-up (T-120→T-1)-5.0%

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