Aquestive Therapeutics: An Update on Anaphylm's FDA Approval Timeline

Aquestive Therapeutics has updated the Anaphylm timeline for FDA approval, with the ticker down 2% since the last article. The company has five areas of focus for 2025, including Anaphylm's potential approval.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) has announced an update to the timeline for FDA approval of Anaphylm™ (epinephrine) Sublingual Film, its innovative treatment for severe allergic reactions, including anaphylaxis. The company's stock has declined by 2% since the last article, reflecting investor sentiment on the delayed approval process.

The update comes as Anaphylm™ prepares for two poster presentations at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit, scheduled for June 27-29 in Chicago, Ill. The presentations, titled "The Physicochemical Properties of Anaphylm Under Extreme Temperatures and Real-World Conditions" and "Epinephrine Delivered via Sublingual Film (Anaphylm) Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses," will highlight the product's unique features and efficacy.

Aquestive Therapeutics is focusing on five key areas for 2025, including the potential FDA approval of Anaphylm™. The company's proprietary product candidate is designed to be a convenient, orally delivered epinephrine option, providing a novel alternative to traditional injectable treatments. The Anaphylm™ film is similar in size to a postage stamp, weighs less than an ounce, and dissolves on contact, making it easy to carry and use in emergency situations.

The company's forward-looking statements include the potential for Anaphylm™ to be the first and only orally delivered epinephrine option in the United States if approved by the FDA. However, the approval process involves several risks, such as delays in clinical development, FDA regulatory hurdles, and competition from other products.

Investors should remain vigilant and monitor the progress of Anaphylm™ and other product candidates, including AQST-108, a topical gel for dermatological conditions. The company's success in navigating these challenges will be critical to its future performance.

References:
[1] https://finance.yahoo.com/news/aquestive-therapeutics-present-positive-data-110000692.html