Aquestive Therapeutics (NASDAQ:AQST) saw its shares plunge about 40% on Friday after the company said the U.S. Food and Drug Administration has raised deficiencies in its New Drug Application for Anaphylm, a sublingual film designed to treat severe allergic reactions.
The FDA informed the company that the identified issues currently “preclude discussion of labeling and post-marketing commitments at this time,” although the agency did not disclose specific details. Regulators added that their review of the application is still in progress and that no final determination has been made ahead of the 31 January 2026 action date.
“Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns,” said Dan Barber, President and Chief Executive Officer of Aquestive.
If approved, Anaphylm would become the first FDA-approved sublingual film for the treatment of severe allergic reactions, including anaphylaxis. The NDA is supported by data from eleven clinical studies, covering roughly 967 total administrations in 411 subjects.
Despite the regulatory setback in the U.S., Aquestive said it continues to advance its international strategy for Anaphylm, with regulatory filings planned in Canada, Europe and the United Kingdom in 2026. The company added that the European Medicines Agency has indicated no additional clinical trials would be required before submission.
At the end of 2025, Aquestive reported cash and cash equivalents of around $120 million, which it believes will be sufficient to support completion of the U.S. approval process—if successful—as well as preparations for launch and ongoing global regulatory efforts.