Aquestive Therapeutics (NASDAQ:AQST) shares rose 9.5% on Monday after the pharmaceutical company reported positive human factors and pharmacokinetic study results for Anaphylm, strengthening its preparations to resubmit a New Drug Application to the U.S. Food and Drug Administration.
The studies evaluated Anaphylm (dibutepinephrine) sublingual film and were designed to address issues raised by regulators during the product’s previous review.
Aquestive plans to resubmit its NDA during the third quarter of 2026, seeking approval of Anaphylm for the treatment of Type 1 allergic reactions, including anaphylaxis.
New packaging significantly reduces opening time
Results from the human factors validation study indicated substantial improvements following changes to Anaphylm’s packaging and instructions for use.
The redesigned packaging reduced the median time required to open the pouch to 3 seconds, compared with 17 seconds in the previous human factors study.
Revised instructions also reduced instances of incorrect film placement by more than 80% compared with the earlier validation study.
The improvements directly address concerns identified by the FDA when it issued a Complete Response Letter to Aquestive in January 2026.
During the earlier study, regulators identified problems including difficulty opening the pouch, accidental tearing of the film and incorrect placement during administration.
In the latest study, the number of participants experiencing difficulty opening the pouch declined to just 1 out of 105, compared with 26 out of 166 previously.
Self-administered Anaphylm produces comparable results
The pharmacokinetic study also provided supportive results for self-administration of Anaphylm.
Participants who administered the treatment themselves recorded a geometric mean Cmax of 391.7 pg/mL and a median Tmax of 12 minutes.
That compared with a Cmax of 357.6 pg/mL and a median Tmax of 12 minutes when the treatment was administered by a clinician.
Manual intramuscular administration, meanwhile, produced a Cmax of 334.5 pg/mL and a median Tmax of 45 minutes.
The results therefore showed that self-administered Anaphylm achieved pharmacokinetic performance comparable to clinician administration while reaching its median maximum concentration considerably faster than manual intramuscular administration.
Misplaced film also delivers meaningful response
Aquestive additionally evaluated Anaphylm when the film was deliberately placed on top of the tongue rather than administered in the intended position.
The company said this arm of the pharmacokinetic study produced clinically meaningful pharmacodynamic results that were comparable to, or greater in magnitude than, those observed with injectable epinephrine.
This finding could be particularly relevant to the product’s potential real-world use, where correct administration may be more difficult during an emergency allergic reaction.
No serious adverse events were reported during the pharmacokinetic study, while no participants across either study required premature removal of the film.
The 9.5% rise in Aquestive shares reflects investor optimism that the latest results have addressed important deficiencies identified in the January Complete Response Letter, potentially strengthening the company’s planned third-quarter 2026 NDA resubmission for Anaphylm.
Aquestive Therapeutics stock price
