Law Firm Investigates Aquestive Therapeutics
The law firm Faruqi & Faruqi, LLP has announced it is investigating claims on behalf of investors in Aquestive Therapeutics. This new securities class action investigation is part of a broader climate of legal vigilance and risk aversion in regulated sectors.
The investigation centers on Aquestive's lead product candidate, Anaphylm, a sublingual film designed to treat severe allergic reactions, including anaphylaxis. The company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm, with a decision date anticipated by January 31, 2026. On January 30, 2026, Aquestive announced that the FDA had issued a Complete Response Letter (CRL) for Anaphylm. The CRL cited issues with the human factors validation study and required a supportive pharmacokinetic study, delaying the potential approval and market launch of the drug. Following the announcement of the FDA's decision, Aquestive's stock price plummeted by approximately 40% intraday. This significant drop in value prompted law firms, including Faruqi & Faruqi and Pomerantz LLP, to launch investigations into potential securities fraud or other unlawful business practices on behalf of investors who suffered substantial losses. This is not the first time Aquestive has faced legal challenges related to an FDA application. In March 2023, the company won a dismissal of a securities class action lawsuit concerning its epilepsy treatment, Libervant. That lawsuit had alleged false and misleading statements about the likelihood of FDA approval for that drug. Despite the setback with Anaphylm, Aquestive has had recent regulatory success with Libervant (diazepam) Buccal Film. The FDA approved the drug in April 2024 for treating seizure clusters in pediatric patients aged two to five, and in December 2024, granted it seven years of orphan drug market exclusivity. Investors are now watching to see how Aquestive addresses the deficiencies identified by the FDA for Anaphylm. The company has stated it plans to resubmit the NDA in the third quarter of 2026. Meanwhile, Aquestive is scheduled to report its fourth-quarter 2025 financial results on March 4, 2026, which may provide further insight into the company's financial health and strategy moving forward.
