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Aquestive Therapeutics Faces Legal Probe After Anaphylm Setback

A 37% plunge in Aquestive Therapeutics stock has triggered a formal investigation by San Francisco law firm Schubert Jonckheer & Kolbe. Attorneys are scrutinizing whether the pharmaceutical company issued false or misleading statements regarding the regulatory progress of its drug candidate, Anaphylm, ahead of a critical FDA review.

Aquestive Therapeutics Faces Legal Probe After Anaphylm Setback
Photo: Bio & News

The legal inquiry centers on disclosures made between June 2025 and January 2026. During this window, Aquestive repeatedly assured shareholders that the approval process for Anaphylm remained on schedule for a January 31, 2026, target date. However, on January 9, 2026, the company disclosed that the FDA had identified significant deficiencies in the New Drug Application, effectively halting discussions on labeling and post-marketing requirements.

Schubert Jonckheer & Kolbe is now evaluating potential claims against the company’s directors and officers for their role in these representations. Shareholders who suffered losses following the market correction are being invited to participate in the firm's investigation into corporate conduct.

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