Why is Faruqi & Faruqi investigating Aquestive Therapeutics?

The firm is investigating potential securities law claims after Aquestive’s stock dropped about 40% following disclosures that the FDA identified deficiencies in its New Drug Application for Anaphylm, raising concerns about regulatory approval and investor losses.

What caused Aquestive Therapeutics’ stock price to fall sharply?

Shares fell after the company disclosed that the FDA found deficiencies in the NDA for its Anaphylm product, preventing discussions on labeling and post-marketing requirements and creating uncertainty before the January 31, 2026 PDUFA date.

What is Anaphylm and why is FDA approval important to investors?

Anaphylm is an experimental sublingual film for treating severe allergic reactions. FDA approval is critical because it affects the product’s ability to reach market, future revenue prospects, and the company’s valuation.

Who may be eligible to participate in the investigation of Aquestive Therapeutics?

Investors who purchased or held Aquestive Therapeutics stock and suffered losses following the FDA disclosure about NDA deficiencies may be eligible to provide information and learn about potential legal options.

What does an FDA deficiency letter mean for a biotech company like Aquestive?

An FDA finding of deficiencies means the agency needs additional information before approving a drug application. This can delay approval, increase costs, and reduce investor confidence, often leading to stock volatility and potential shareholder claims.

Aquestive Therapeutics, Inc. - Faruqi & Faruqi LLP

Aquestive Therapeutics, Inc.

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Case Details

Ticker AQST

Class Period 06/16/2025 - 01/08/2026

Lead Plaintiff Deadline 05/04/2026

Days Left to Seek Plaintiff

If you are an Aquestive Therapeutics investor who suffered a loss and would like to learn more, you can provide your information below

If you purchased or acquired securities in Aquestive between June 16, 2025 and January 8, 2026 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).

Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST) and reminds investors of the May 4, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose the true state of Aquestive’s NDA for Anaphylm; pertinently, Aquestive concealed or otherwise minimized the significance of the human factors involved in the use and deployment of its sublingual film, such as packaging, use, administration, and labeling.

Lead Plaintiff Deadline: May 4, 2026

Call Partner Josh Wilson at 877-247-4292 or 212-983-9330 (Ext. 1310)
Or submit your information below to learn about your rights.

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