Aquestive Therapeutics Inc. (NASDAQ:AQST) stock is trading lower on Friday, with a session volume of 5.68 million compared to the average volume of 2.79 million, as per data from Benzinga Pro.
Why Did It Fall?
The company on Friday said the U.S. Food and Drug Administration (FDA) has identified deficiencies in Anaphylm’s New Drug Application (NDA) that preclude discussion of labeling and post-marketing commitments at this time.
Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns. The FDA stated that the notification does not reflect a final decision on the pending application, and the FDA’s review remains ongoing.
Anaphylm (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. The company seeks approval for severe allergic reactions, including anaphylaxis.
Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration.
Aquestive Therapeutics is advancing global expansion of Anaphylm with plans to submit for regulatory approval in Canada, Europe, and the U.K. in 2026.
What’s Next?
The company is in contact with the FDA to gather further information about the deficiencies to address those deficiencies before the scheduled PDUFA action date of January 31, 2026.
The FDA has indicated that the review remains ongoing and further clarified that a Discipline Review Letter will not be issued, while information requests are possible during the remaining review period.
However, further delays in communicating the specific deficiencies may lead to a delay in the potential approval of Anaphylm.
Aquestive ended 2025 with approximately $120 million in cash and cash equivalents. The company continues to believe this funding is sufficient to complete the Anaphylm approval and launch processes in the U.S., if approved by the FDA, while progressing Anaphylm in other key markets outside the U.S.
In September 2025, ARS Pharmaceuticals Inc. (NASDAQ:SPRY) filed a petition urging the FDA to delay approval of Aquestive’s experimental epinephrine treatment, citing safety, dosing, and real-world use concerns.
AQST Price Action: Aquestive Therapeutics shares were down 40.18% at $3.71 at the time of publication on Friday, according to Benzinga Pro data.
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