Overview

A class action lawsuit has been filed against Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ : AQST) and the Company’s Chief Executive Officer (“CEO”) (collectively, “Defendants”), alleging violations of the federal securities laws. The Aquestive lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired Aquestive common stock between June 16, 2025, and January 8, 2026, inclusive (the “Class Period”). Investors have until May 4, 2026, to seek appointment as lead plaintiff of the Aquestive class action lawsuit.

Aquestive is a pharmaceutical company whose main focus is treatments for anaphylaxis and epilepsy. One of the Company’s key pharmaceuticals is Anaphylm, a treatment for severe allergic reactions. 

The complaint alleges that throughout the Class Period Defendants made materially false and misleading statements regarding the regulatory review and expected approval timeline for Anaphylm. Specifically, Defendants represented that the Company’s New Drug Application (“NDA”) for Anaphylm remained on track for approval by the U.S. Food and Drug Administration (“FDA”) by the January 31, 2026 Prescription Drug User Fee Act (“PDUFA”) target date.

These statements were misleading because Defendants failed to disclose that the FDA had identified deficiencies with Aquestive’s NDA for Anaphylm. In order for the FDA to grant approval for a product, any deficiencies with its NDA must be remedied.  Accordingly, the launch of Anaphylm was delayed, indicating that Aquestive failed to obtain approval for Anaphylm by the PDUFA date.

The truth was revealed on January 9, 2026, when Aquestive announced that the Company was in receipt of a letter from the FDA identifying deficiencies that precluded labeling discussions for Anaphylm. Moreover, Aquestive revealed that the letter from the FDA confirmed that the agency’s review of Anaphylm NDA was ongoing and no final decision had been made, which effectively delayed the approval of Anaphylm well beyond the January 31, 2026 PDUFA date.

On this news, the price of Aquestive’s common stock plummeted, declining by more than 37%, falling from a closing price of $6.21 per share on January 8, 2026, to close at $3.91 per share on January 9, 2026.

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If you purchased or otherwise acquired Aquestive common stock between June 16, 2025, and January 8, 2026, and you wish to serve as lead plaintiff in this lawsuit, you are encouraged to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt attorneys Brian O’Mara and Hani Farah by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the Aquestive class action lawsuit is May 4, 2026.