Aquestive(US:AQST) Businesswire·2026-01-09 16:49Core Viewpoint - Aquestive Therapeutics, Inc. is facing significant challenges following the FDA's identification of deficiencies in its New Drug Application for Anaphylm, leading to a sharp decline in its stock price by approximately 40% [2]. Group 1: Company Overview - Aquestive Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative treatments for severe allergic reactions, including anaphylaxis [2]. Group 2: Regulatory Challenges - The FDA has identified deficiencies in the New Drug Application (NDA) for Anaphylm, which is a sublingual film intended for treating severe allergic reactions [2]. - These deficiencies currently prevent discussions regarding labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026, PDUFA action date [2]. Group 3: Market Reaction - Following the FDA's announcement, shares of Aquestive Therapeutics, Inc. experienced a significant intraday drop of approximately 40% [2].