Aquestive Therapeutics Faces FDA Setback for Anaphylm Drug

Shares plunge 40% after FDA identifies deficiencies in new drug application

Published on Feb. 16, 2026

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) saw its stock price plummet approximately 40% on Friday after the company disclosed that the U.S. Food and Drug Administration (FDA) had identified deficiencies in its New Drug Application (NDA) for Anaphylm, its experimental sublingual film for the treatment of severe allergic reactions, including anaphylaxis. The FDA advised that the unidentified deficiencies currently prevent discussions of labeling and post-marketing requirements, raising concerns about the application's approvability ahead of the January 31, 2026, PDUFA action date.

Why it matters

Anaphylm, if approved, would provide a new treatment option for those suffering from severe allergic reactions, including anaphylaxis. The FDA's identification of deficiencies in the NDA raises doubts about the drug's path to approval, which could impact Aquestive's future revenue and growth prospects.

The details

Aquestive Therapeutics is a pharmaceutical company focused on developing and commercializing differentiated products to address unmet medical needs. The company's Anaphylm drug is a sublingual film formulation designed to provide rapid relief for severe allergic reactions. The FDA's identification of deficiencies in the NDA suggests that the agency has concerns about the drug's safety, efficacy, or manufacturing processes, which could delay or prevent its approval.

  • The FDA advised Aquestive of the deficiencies in the Anaphylm NDA on February 15, 2026.
  • The PDUFA action date for the Anaphylm NDA is January 31, 2026.

The players

Aquestive Therapeutics, Inc.

A pharmaceutical company focused on developing and commercializing differentiated products to address unmet medical needs.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

Anaphylm

Aquestive Therapeutics' experimental sublingual film for the treatment of severe allergic reactions, including anaphylaxis.

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What they’re saying

“If you suffered significant losses in Aquestive Therapeutics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).”

— James (Josh) Wilson, Securities Litigation Partner, Faruqi & Faruqi, LLP (Faruqi & Faruqi, LLP)

What’s next

The FDA will continue to review the Anaphylm NDA, and a decision on the drug's approval is expected by the January 31, 2026, PDUFA action date.

The takeaway

The FDA's identification of deficiencies in Aquestive Therapeutics' Anaphylm NDA is a significant setback for the company, as it raises doubts about the drug's path to approval and could impact the company's future revenue and growth prospects. Investors who have suffered significant losses may want to consult with legal counsel to discuss their options.