Aquestive Therapeutics, Inc.
Case Overview
| Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 05/09/2026 |
| Status: | Status: Investigating |
| Company Name: | Company Name: Aquestive Therapeutics, Inc. |
| Court: | Court: District of New Jersey |
| Case Number: | Case Number: 3:26cv02317 |
| Class Period: | Class Period: 06/16/2025 - 01/08/2026 |
| Ticker: | Ticker: AQST |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ:AQST) securities during the period of June 16, 2025 through January 8, 2026, inclusive (“the Class Period”).
According to the complaint, the Company provided investors with positive statements while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Aquestive's New Drug Application (NDA) for Anaphylm (Dibutepinephrine) sublingual film; 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.
On January 9, 2026, 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 Prescription Drug User Fee Act date. On this news, the price of Aquestive shares declined by $2.30 per share, or approximately 37%, from $6.21 per share on January 8, 2026 to close at $3.91 on January 9, 2026.