Aquestive Stock Slides After FDA Flags Issues With Allergy Drug Application

Core Viewpoint - Aquestive Therapeutics Inc. is experiencing a decline in stock price due to identified deficiencies in the New Drug Application for Anaphylm, which is a polymer matrix-based epinephrine prodrug product candidate aimed at treating severe allergic reactions, including anaphylaxis [2][3][6] Group 1: Stock Performance - The stock of Aquestive Therapeutics is trading lower, with a session volume of 5.68 million compared to the average volume of 2.79 million [1] - At the time of publication, shares were down 40.18% at $3.71 [6] Group 2: FDA Review and Deficiencies - The FDA has identified deficiencies in Anaphylm's New Drug Application that prevent discussions on labeling and post-marketing commitments [2] - The specific deficiencies have not been disclosed, but the company is actively working to understand and resolve these concerns [2][4] - The FDA's review of the application remains ongoing, and a Discipline Review Letter will not be issued, although information requests may occur during the review period [4] Group 3: Product Details and Future Plans - Anaphylm is designed to be a sublingual film that is similar in size to a postage stamp and begins to dissolve on contact, requiring no water or swallowing for administration [3] - The company plans to submit for regulatory approval of Anaphylm in Canada, Europe, and the U.K. by 2026 [3] Group 4: Financial Position and Future Outlook - As of the end of 2025, the company had approximately $120 million in cash and cash equivalents, which is believed to be sufficient for completing the Anaphylm approval and launch processes in the U.S. if approved [5] - Delays in communicating specific deficiencies may lead to further delays in the potential approval of Anaphylm [5]