Robbins LLP Informs Investors of Aquestive Therapeutics Class Action Lawsuit

Pharmaceutical company faces allegations of misleading investors about Anaphylm drug approval

Published on Mar. 6, 2026

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Robbins LLP has filed a class action lawsuit on behalf of investors who purchased or acquired Aquestive Therapeutics, Inc. (NASDAQ: AQST) 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, causing the stock price to decline over 37% when the company announced FDA deficiencies that delayed approval.

Why it matters

This case highlights the importance of pharmaceutical companies providing accurate and timely information to investors about the regulatory approval process for their drug candidates. Misleading investors can lead to significant stock price declines and legal action.

The details

According to the complaint, Aquestive created the false impression that it was on track to receive FDA approval for Anaphylm by the January 31, 2026 PDUFA date. However, the FDA had actually identified deficiencies in Aquestive's NDA that precluded labeling discussions and post-marketing commitments, effectively delaying the approval of Anaphylm. On January 9, 2026, Aquestive announced the FDA's letter identifying these deficiencies, causing the stock price to plummet.

  • Aquestive filed its NDA for Anaphylm in June 2025.
  • The PDUFA date for the Anaphylm NDA was January 31, 2026.
  • On January 9, 2026, Aquestive announced the FDA's letter identifying deficiencies in the Anaphylm NDA.

The players

Aquestive Therapeutics, Inc.

A pharmaceutical company committed to advancing medicines to improve patients' lives through innovative science and delivery technologies.

Robbins LLP

A recognized leader in shareholder rights litigation, representing shareholders in recovering losses, improving corporate governance, and holding company executives accountable.

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What’s next

The lead plaintiff in the class action lawsuit will be determined, and the case will proceed through the legal process.

The takeaway

This case highlights the importance of pharmaceutical companies providing accurate and transparent information to investors about the regulatory approval process for their drug candidates. Misleading investors can lead to significant legal and financial consequences.