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Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update

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WARREN, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquest...

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AI Summary

FDA identifies deficiencies in Anaphylm NDA, delaying labeling discussions. Ongoing review process remains, with no final decision from FDA yet. Company confident in Anaphylm’s potential as a sublingual film for allergies. Global expansion efforts include Canada, Europe, and the UK for Anaphylm. Company ended 2025 with approximately $120 million in cash reserves.

Sentiment Rationale

Identified deficiencies from the FDA in Anaphylm's NDA signal risks that could negatively impact stock valuation. Historical examples show similar FDA communications often lead to short-term declines in stock prices until issues are resolved.

Trading Thesis

Immediate concerns regarding the NDA could impact stock prices, but ongoing confidence in Anaphylm suggests longer-term potential remains intact.

Market-Moving

  • FDA communication of deficiencies could lead to price volatility for AQST.
  • Successful resolution may bolster investor confidence in Anaphylm's market potential.
  • Global regulatory expansions could attract new investments and partnerships.
  • Cash reserves will support operational stability amid regulatory challenges.
  • Positive EMA feedback accelerates European market entry for Anaphylm.

Key Facts

  • FDA identifies deficiencies in Anaphylm NDA, delaying labeling discussions.
  • Ongoing review process remains, with no final decision from FDA yet.
  • Company confident in Anaphylm’s potential as a sublingual film for allergies.
  • Global expansion efforts include Canada, Europe, and the UK for Anaphylm.
  • Company ended 2025 with approximately $120 million in cash reserves.

Companies Mentioned

  • EPI (EPI)
  • ALGS (ALGS)
  • AVXL (AVXL)

Corporate Developments

The FDA's feedback is crucial for AQST's upcoming regulatory outcomes and potential commercial launch, significantly influencing investor perceptions and stock activity.

Aquestive Therapeutics Provides Update on Anaphylm™ Regulatory Development and Business Strategy

WARREN, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) has announced important updates regarding its Anaphylm™ (dibutepinephrine) sublingual film and its business progress. The company has received feedback from the FDA, indicating the identification of deficiencies in its New Drug Application (NDA), which currently prevents discussions related to labeling. However, the FDA's review process for Anaphylm is still ongoing, and no final decision has yet been made.

FDA Communication and Future Steps

In a recent statement, Dan Barber, President and CEO of Aquestive, remarked, “The FDA notified us that it had identified deficiencies in the NDA for Anaphylm that preclude discussion of labeling and post-marketing commitments at this time.” Although the specific deficiencies were not disclosed, Aquestive is actively working to address these concerns. The FDA clarified that this communication is not a final decision, and the review process remains active.

Continuing Commitment to Anaphylm

Despite the challenges, Barber expressed confidence in Anaphylm's potential to become the first FDA-approved sublingual epinephrine treatment. He emphasized the product's design, which aims to be easy-to-use, fast-acting, and portable. Moreover, the company is moving forward with global regulatory expansion plans for Anaphylm, with anticipated submissions for approval in Canada, Europe, and the United Kingdom in 2026.

Clinical Development Details

The NDA submission for Anaphylm is supported by an extensive clinical development program, comprising:

  • Eleven independent clinical studies
  • Approximately 967 total administrations
  • Participation of 411 subjects, including 840 single-dose and 127 repeat-dose exposures

The studies have demonstrated that Anaphylm offers a pharmacokinetic (PK) profile comparable to leading epinephrine auto-injectors and has a safety profile similar to that of epinephrine.

Global Expansion Strategy

Aquestive is advancing its regulatory strategy in key markets:

  • Canada: Expected New Drug Submission (NDS) in the first half of 2026.
  • Europe: Plans to submit the marketing authorization application in the second half of 2026.
  • United Kingdom: Feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) anticipated in the first quarter of 2026.

These initiatives aim to expand access to Anaphylm’s innovative non-invasive epinephrine therapy, improving severe allergy management.

Financial Overview

Aquestive Therapeutics reported unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025. This funding is expected to support the Anaphylm approval process and its subsequent launch in the U.S., contingent upon FDA approval.

About Anaphylm™ and Aquestive Therapeutics

Anaphylm™ (dibutepinephrine) Sublingual Film is designed as a polymer matrix-based epinephrine prodrug. It is convenient for administration, requiring no water or swallowing, and is portable and resilient to various environmental conditions. The product's trade name has been conditionally approved by the FDA pending the approval of Anaphylm itself.

Aquestive is committed to transforming patient care through its innovative delivery technologies and oral formulations. The company focuses on developing alternatives to conventional therapies, including its upcoming epinephrine prodrug for severe allergic reactions.

Forward-Looking Statements

Some statements in this release are forward-looking as defined by the Private Securities Litigation Reform Act. Words like “believe,” “expect,” and “intend” are used to identify these statements, including those regarding the advancement of Anaphylm™ through clinical development and its potential approval by the FDA.

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