Usability/Clinical CRL, Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
Price into the decision (T-120)
Daily close, T-120 (8/18/25) through T+5. Run-up high $7.49 on 10/24/25, low $2.95 on 1/30/26 (T-120 to T-1). FDA decision 2/2/26. Historical price action, not a forecast.
CRL reasonUsability/Clinical, Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
Not in this review cycle. On February 2, 2026 the FDA issued a Complete Response Letter, declining to approve the application for Anaphylm in its current form. A CRL is not final; the primary source is linked on this page.
How did AQST stock react to the FDA decision?
On the decision day AQST moved +39.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.