aibioAquestive faces securities class action and derivative suit over Anaphylm NDA statements
Tickers AQST
Modica v. Aquestive names the company and chief executive Daniel Barber in New Jersey federal court. A derivative suit, Wilson v. Brown, is stayed behind it.
Key facts
- Company
- Aquestive Therapeutics, Inc. (NASDAQ: AQST)
- News type
- Legal
- Primary source
- Aquestive Therapeutics 10-Q for the quarter ended June 30, 2026 (SEC EDGAR)
Aquestive Therapeutics, Inc. (Nasdaq: AQST) disclosed in its 10-Q filed August 11, 2026 a putative securities class action, Modica v. Aquestive Therapeutics, Inc. and Daniel Barber. It was filed on March 5, 2026 in the U.S. District Court for the District of New Jersey. The defendants are the company and Mr. Barber, who is its president and chief executive officer. The 10-Q does not give a case number.
A shareholder derivative suit, Wilson v. Brown, et al., followed on April 15, 2026 in the same court. It names certain directors and officers as defendants, whom the 10-Q does not list, and the company as nominal defendant.
The case
The class action covers investors who bought the company's securities between June 16, 2025 and January 8, 2026. It asserts Section 10(b) claims against all defendants and Section 20(a) claims against Mr. Barber. The complaint alleges that defendants made misstatements or failed to disclose facts about the new drug application for Anaphylm. It seeks monetary damages in an unspecified amount. The class period ends January 8, 2026. On January 9, 2026, Aquestive announced in an 8-K that the FDA had identified deficiencies in the Anaphylm application. The notice did not specify them. The same 8-K reported approximately $120 million in cash and cash equivalents as of December 31, 2025.
The derivative complaint asserts Section 14(a) claims against the director defendants. It asserts breach of fiduciary duty, aiding and abetting that breach, and waste of corporate assets against all individual defendants. It alleges they failed to oversee, and misrepresented or failed to disclose facts about, the Anaphylm application. It seeks damages and governance reforms.
Defendants
Class action: Aquestive Therapeutics, Inc. and Daniel Barber.
Derivative suit: the 10-Q refers only to "certain individual directors and officers" and does not list them, and it does not say who "Brown" is. Aquestive's definitive proxy statement, filed April 24, 2026, after the suit was filed, lists a board of seven: Mr. Barber, Gregory B. Brown, M.D. (chair), John S. Cochran (vice chair), Abigail L. Jenkins, Julie Krop, M.D., Timothy E. Morris and Marco Taglietti, M.D. No filing we reviewed states that any of the six non-employee directors is a defendant.
Where it stands
The 10-Q says the lead plaintiff selection process is pending. After selection, the company expects to file a motion to dismiss. The court has designated the derivative action as related to the class action and has stayed it until the motion to dismiss is decided. The company says it cannot predict the outcome of either case or estimate a possible loss or range of loss. On September 17, 2026, Aquestive announced that it had resubmitted its new drug application for Anaphylm to the FDA.
Related matters
The 10-Q also describes Suboxone product liability litigation, consolidated as a multidistrict proceeding in the Northern District of Ohio since February 2, 2024, and three proposed class actions in Canada, two in British Columbia and one in Quebec. The Quebec case is heading to an authorization hearing with no date set. Indivior continues to assume defense costs under a contractual indemnification obligation. A tort suit by Neurelis, Inc. was settled in December 2025 and dismissed with prejudice on April 3, 2026.
Why it matters to shareholders
The 10-Q gives no loss estimate for the securities or derivative cases, and it does not discuss insurance for them. The stay of the derivative suit means that case waits on the motion to dismiss in the class action.