Aquestive Therapeutics, Inc. Class Action Lawsuit – AQST

Introduction to Aquestive Therapeutics, Inc. (AQST) Securities Class Action Lawsuit

A securities fraud class action has been filed under the federal securities laws against Aquestive Therapeutics, Inc. (NASDAQ: AQST) and its CEO Daniel Barber on behalf of investors who purchased Aquestive securities traded on the NASDAQ under ticker AQST between June 16, 2025 and January 8, 2026. Investors allege that defendants misrepresented the status of the company's New Drug Application for Anaphylm, a sublingual film epinephrine treatment for anaphylaxis, repeatedly assuring shareholders that the U.S. Food and Drug Administration approval process was on track for January 31, 2026, the PDUFA action date. In reality, the complaint alleges, Aquestive concealed or minimized significant deficiencies related to human factors-including packaging, use, administration, and labeling-that would ultimately prevent approval. When the FDA disclosed these deficiencies in January 2026 and issued a Complete Response Letter rejecting the application, Aquestive's stock price collapsed, falling over 37% in a single day.

Aquestive Therapeutics, Inc. (AQST) Securities Lawsuit Case Details

Case Name: Vincent Modica v. Aquestive Therapeutics, Inc., et al.

Case No.: 3:26-cv-02317

Jurisdiction: U.S. District Court, District of New Jersey

Filed on: March 5, 2026

Aquestive Therapeutics, Inc. (AQST) Company Profile

Aquestive Therapeutics is a pharmaceutical company based in Warren, New Jersey, and publicly traded on the NASDAQ committed to advancing medicines through innovative science and delivery technologies, including its PharmFilm oral drug delivery platform. The Company’s pipeline includes treatments for neurologic conditions such as epilepsy. One of the company's key pharmaceuticals is Anaphylm, an allergic reaction treatment that is a sublingual film formulation of epinephrine, also known as AQST-109, designed for emergency treatment of severe allergic reactions.

Aquestive Therapeutics, Inc. (AQST) Securities Lawsuit Class Period

June 16, 2025 – January 8, 2026, inclusive.

All investors who purchased or otherwise acquired Aquestive securities during the Class Period, including NASDAQ-listed AQST common stock, may be eligible to join the Aquestive Therapeutics, Inc. (AQST) class action lawsuit.

Allegations in the Aquestive Therapeutics, Inc. (AQST) Securities Class Action Lawsuit

The complaint targets Aquestive Therapeutics, Inc. and its CEO Daniel Barber for allegedly misleading investors about the regulatory approval timeline for Anaphylm, a device-free sublingual film epinephrine treatment designed for anaphylaxis. On June 16, 2025, CEO Barber announced the FDA's acceptance of the company's New Drug Application, the Anaphylm NDA, declaring that Anaphylm represented "a breakthrough in anaphylaxis treatment" and emphasizing its convenience as a product "thinner than a credit card" that required no special storage. He stated the company was "one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most." During this period, defendants continued to express confidence in the approval process. On August 11, 2025, Barber announced preparations for "a potential U.S. launch in 2026" with "regulatory progress on track." The following day, during an earnings call, he told investors the company was "now less than 6 months away" from the FDA action date and assured them: "I'm pleased to tell you this morning that we are on track across the important elements of Anaphylm. We are on track in our FDA review process." On November 5, 2025, after the FDA decided not to convene an Advisory Committee, Barber stated that this decision "further advances our regulatory path" and that the NDA "remains on track for the scheduled January 31, 2026 PDUFA goal date," a PDUFA action date that investors watched closely.

According to the complaint, defendants created the false impression that Aquestive was on track to receive approval for Anaphylm by the January 31, 2026 PDUFA date while concealing or minimizing the significance of human factors deficiencies involving the drug's packaging, use, administration, and labeling, deficiencies in the NDA that precluded labeling discussions and post-marketing commitments. The lawsuit alleges that the FDA had identified deficiencies preventing approval discussions and raising approvability concerns, which meant approval could not be granted without remediation. These material omissions caused investors to purchase Aquestive securities at artificially inflated prices throughout the class period.

The Truth Emerges

On January 9, 2026, Aquestive disclosed that the company had received an FDA letter identifying deficiencies in the NDA that precluded discussion of post-marketing commitments, effectively halting approval and labeling discussions. The announcement stated that although the notification did not specify the deficiencies, the FDA's concerns prevented the approval process from moving forward, and the company was working to understand and resolve the issues. Less than a month later, on February 2, 2026, Aquestive announced that the FDA had issued a Complete Response Letter on January 30, 2026, one day before the January 31 PDUFA action date, formally rejecting the Anaphylm application. The CRL cited specific deficiencies in the Anaphylm human factors validation study, including instances of difficulty opening the pouch and incorrect film placement, which the FDA believed could cause significant safety issues in the setting of anaphylaxis.

These revelations directly contradicted defendants' repeated assurances throughout the class period that the approval process was on track and progressing smoothly toward the January 31, 2026 deadline. The disclosure exposed that significant regulatory obstacles existed well before the PDUFA date, undermining the optimistic narrative defendants had presented to investors about the drug's imminent approval and commercial launch.

Market Reaction

The market reacted swiftly to the January 9, 2026 disclosure of FDA deficiencies. Aquestive's common stock on the NASDAQ fell from a closing price of $6.21 per share on January 8, 2026 to $3.91 per share on January 9, 2026, a decline of $2.30 or over 37% in a single day.

Next Steps

●      The Court will issue its order for lead plaintiff and counsel in the weeks after submissions are due.

●      The Court will then consider motion for class certification.

●      The Court will later consider a Motion to Dismiss.

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. No specific outcomes are guaranteed.

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