Aquestive Resubmits Anaphylm NDA to FDA, Paving Path to Approval
AQST sits 67% above its 52-week low of $2.93.
Summary
Aquestive resubmitted its Anaphylm NDA to the FDA, supported by improved human factors data (pouch-opening time cut from 17 to 3 seconds) and a clean confirmatory PK study. The company is requesting expedited review and planning ex-US filings.
Key Events · Product Development and Regulatory · AQST
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Anaphylm NDA Resubmitted to FDA
Aquestive formally resubmitted its NDA for Anaphylm (dibutepinephrine) sublingual film on September 17, 2026, addressing the FDA's January 30, 2026 Complete Response Letter.
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Human Factors Data Shows Major Improvement
Median pouch-opening time fell from 17 seconds to 3 seconds in the resubmission human factors study (N=105), with zero participants unable to open the pouch and zero torn films.
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Confirmatory PK Study Clean
No protocol-defined use errors were observed in the self-administration arm of the confirmatory PK study, which used the revised packaging and instructions.
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Expedited Review Requested
Aquestive intends to request expedited review of the NDA resubmission, though the FDA will determine the classification and review timeline after its initial review.
Analysis · AQST · Life Sciences
Aquestive has formally resubmitted its New Drug Application for Anaphylm, its needle-free epinephrine sublingual film, to the FDA. This is the critical next step after the January 2026 Complete Response Letter. The resubmission is backed by new human factors data showing median pouch-opening time dropped from 17 seconds to 3 seconds, and a confirmatory PK study with no protocol-defined use errors in self-administration. If the FDA accepts the resubmission and grants expedited review, Anaphylm could be approved and launched in 2027, unlocking a potential >$1B annual revenue opportunity. The company also disclosed plans to file in Canada before end of 2026 and in the EU in Q1 2027.
How filings like this one have moved
In the 30 days to Sep 30, 2026, 34.9% of the 1009 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was -0.52%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, AQST was trading at $4.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $605M. The 52-week trading range was $2.93 to $7.55. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.