AQST Stock Up as FDA Skips Advisory Meeting to Discuss Anaphylm NDA

Core Viewpoint - The FDA has informed Aquestive Therapeutics that no advisory committee meeting is required for the NDA of Anaphylm, indicating the target action date remains January 31, 2026 [1][5][7]. Company Developments - Shares of Aquestive Therapeutics rose by 28.1% following the FDA announcement [2][7]. - The stock has increased by 42.2% year-to-date, outperforming the industry average increase of 11.7% [4]. - The NDA for Anaphylm was accepted by the FDA in June 2025, with the target action date set for January 31, 2026 [5][7]. - Anaphylm is being developed as a non-invasive oral epinephrine product for treating severe allergic reactions, including anaphylaxis [6][8]. Market Potential - If approved, Anaphylm would be the first non-invasive, orally delivered epinephrine product approved by the FDA for severe allergic reactions [6][8]. - The management believes Anaphylm offers greater convenience compared to traditional autoinjectors [7]. - The company has secured $160 million in financing to support the potential launch of Anaphylm in the U.S. in Q1 2026 [8].