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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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 suffered significant losses in Aquestive Therapeutics stock or options 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).

STOCK DROP: Shares of Aquestive Therapeutics, Inc. (NASDAQ: AQST) 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.

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