Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
CMC/Inspection CRL, Pre-license inspection deficiencies at the Reykjavik manufacturing facility (golimumab biosimilar AVT05); no other issues cited.
Price into the decision (T-120)
Daily close, T-120 (5/16/25) through T+5. Run-up high $11.45 on 6/6/25, low $7.82 on 9/18/25 (T-120 to T-1). FDA decision 11/2/25. Historical price action, not a forecast.
CRL reasonCMC/Inspection, Pre-license inspection deficiencies at the Reykjavik manufacturing facility (golimumab biosimilar AVT05); no other issues cited.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMicro
Cohort decision-day move (history)4.7% median (n=312)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was AVT05 approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for AVT05 in its current form, was announced on November 2, 2025. A CRL is not final; the primary source is linked on this page.
How did ALVO stock react to the FDA decision?
On the decision day ALVO moved -34.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.