Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
The FDA's own letter · Complete Response Letter, BLA 761459 (PDF), dated April 22, 2026, released under FDA's CRL transparency program. The company announced the decision on April 23, 2026; the FDA acted on April 22, 2026.
Sections the letter addresses (its own headings, read from the PDF's text layer; labeling and administrative sections omitted): Facility Inspections; Product Quality.
✕ COMPLETE RESPONSE LETTER
AbbVie Inc., trenibotulinumtoxinE (TrenibotE) · Moderate to severe glabellar lines.
Run-up into the decision (T-120 → T+5)
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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was trenibotulinumtoxinE (TrenibotE) approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for trenibotulinumtoxinE (TrenibotE) in its current form, was announced on April 23, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind trenibotulinumtoxinE (TrenibotE)?
trenibotulinumtoxinE (TrenibotE) is an AbbVie Inc. (ABBV) program. The company announced the FDA decision on April 23, 2026; the FDA's own record of the decision 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.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.