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ABBV FDA decision: Apr 23, 2026

Updated ·next FDA decision on the calendar
✕ COMPLETE RESPONSE LETTER

AbbVie Inc.: trenibotulinumtoxinE (TrenibotE) · Moderate to severe glabellar lines.

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

PDUFA 4/23/26$236.28$200.511/6/25
Daily close, T-120 (11/6/25) through T+5. Run-up high $236.28 on 12/1/25, low $200.5 on 4/22/26 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-23
OutcomeCRL
Drug / candidatetrenibotulinumtoxinE (TrenibotE)
CompanyAbbVie Inc.
120-day run-up (T-120→T-1)-10.9%

Questions

Was trenibotulinumtoxinE (TrenibotE) approved by the FDA?

Not in this review cycle. On April 23, 2026 the FDA issued a Complete Response Letter, declining to approve the application for trenibotulinumtoxinE (TrenibotE) in its current form. A CRL is not final; the primary source is linked on this page.

Which company is behind trenibotulinumtoxinE (TrenibotE)?

trenibotulinumtoxinE (TrenibotE) is a AbbVie Inc. (ABBV) program. The FDA decision came on April 23, 2026; the company's own announcement is linked on this page.

How did ABBV stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), ABBV moved -10.9%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.