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Home › FDA Decisions › AQST 2026-02-02

AQST FDA Decision CRL · 2026-02-02

Rebuilt daily·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
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)

PDUFA 2/2/26$7.49$2.958/18/25
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.

Decision facts

FDA decision date2026-02-02
Outcome✗ CRL✓ source-verified
Primary sourceSEC filing 0001398733-26-000005 of 2026-02-02 containing 'complete response lett
Decision-day move+39.0%
T-120 run-up (low→high)+27.0% ($2.95→$7.49)
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)3.7% median (n=302)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

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

Specialist biotech funds holding AQST, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
RTW Investments7,426,471$30.9 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was Anaphylm approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for Anaphylm in its current form, was announced on February 2, 2026. 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.