Bragar Eagel & Squire Urges Aquestive Investors to Contact Firm Before Deadline

Law firm announces class action lawsuit over alleged FDA deficiencies with Anaphylm drug application.

Mar. 30, 2026 at 10:15pm

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A photorealistic studio still life featuring a shiny metal pill bottle and a stack of financial documents on a clean, monochromatic background, conceptually representing the abstract themes of pharmaceutical regulation, corporate strategy, and investor risk.A pharmaceutical lawsuit over alleged regulatory missteps underscores the financial risks facing biotech investors.NYC Today

Bragar Eagel & Squire, P.C., a national stockholder rights law firm, has filed a class action lawsuit against Aquestive Therapeutics, Inc. (NASDAQ:AQST) on behalf of investors who purchased Aquestive securities between June 16, 2025 and January 8, 2026. The lawsuit alleges that Aquestive misled investors about the status of its New Drug Application (NDA) for the Anaphylm drug, falsely claiming it was on track for FDA approval by the January 31, 2026 deadline when the agency had actually identified deficiencies that would delay approval.

Why it matters

This lawsuit highlights the risks investors face when companies provide overly optimistic updates about the regulatory approval process for new drugs. Aquestive's alleged misrepresentations about the status of its Anaphylm NDA led to a significant stock price drop when the truth was revealed, causing losses for shareholders. The case also underscores the importance of thorough due diligence when investing in pharmaceutical companies with pending drug applications.

The details

According to the complaint, Aquestive created the false impression during the class period that its Anaphylm NDA was on track for FDA approval by the January 31, 2026 PDUFA date. However, the FDA had actually identified deficiencies with the NDA that would prevent the agency from moving forward with labeling discussions and post-marketing commitments, effectively delaying Anaphylm's approval. On January 9, 2026, Aquestive announced the FDA's letter identifying these deficiencies, causing the company's stock price to plummet over 37%.

  • The class period runs from June 16, 2025 to January 8, 2026.
  • The FDA's PDUFA date for the Anaphylm NDA was January 31, 2026.
  • Aquestive announced the FDA's deficiency letter on January 9, 2026.

The players

Bragar Eagel & Squire, P.C.

A nationally recognized stockholder rights law firm that filed the class action lawsuit against Aquestive Therapeutics.

Aquestive Therapeutics, Inc.

A pharmaceutical company that develops and commercializes complex drug formulations, including the Anaphylm drug at the center of this lawsuit.

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What they’re saying

“If you purchased or acquired Aquestive securities between June 16, 2025 to January 8, 2026 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Melissa Fortunato directly at (212) 355-4648.”

— Brandon Walker, Litigation Partner, Bragar Eagel & Squire

What’s next

Investors have until May 4, 2026 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

The takeaway

This case highlights the importance of pharmaceutical companies providing accurate and transparent updates to investors about the regulatory approval process for new drugs. Aquestive's alleged misrepresentations about the status of its Anaphylm NDA led to significant losses for shareholders when the truth was revealed, underscoring the risks investors face when investing in the biotech sector.