A securities class action has been filed against Aquestive Therapeutics, Inc. (AQST) on behalf of all investors who purchased or otherwise acquired Aquestive securities between June 16, 2025 through January 8, 2026. This case has been filed in the USDC – NJ.
Shares of Aquestive Therapeutics plunged approximately 40% intraday on Friday after the company disclosed that the U.S. Food and Drug Administration (FDA) identified deficiencies in its New Drug Application (NDA) for Anaphylm, its experimental sublingual film for the treatment of severe allergic reactions, including anaphylaxis. The FDA advised that the unidentified deficiencies currently prevent discussions of labeling and post-marketing requirements, raising concerns about the application’s approvability ahead of the January 31, 2026, PDUFA action date.