Aquestive received an FDA letter indicating deficiencies in the Anaphylm NDA application. The FDA review of Anaphylm NDA is ongoing with no final decision made yet. There are global regulatory expansion activities in Canada, Europe, and the UK for Anaphylm. The company reported unaudited cash and cash equivalents of approximately $120 million as of December 31, 2025.
FDA Notification of Deficiencies
The FDA identified deficiencies in Anaphylm NDA, precluding labeling discussions at this time.
Anaphylm Global Expansion
Aquestive has plans to submit for regulatory approval in Canada, Europe, and the UK in 2026.
Clinical Development Program
The company has a comprehensive program with 11 independent clinical studies supporting the Anaphylm NDA submission.
Market Expansion Strategy
Initiating regulatory engagements in Canada, Europe, and the UK to expand access globally.
- The notification of deficiencies in the NDA may lead to delays in the potential approval of Anaphylm. Anaphylm's unique sublingual film design aims to provide an easy-to-use and portable option for severe allergy management. There are expectations for growth and potential approval of Anaphylm in the U.S. and worldwide with the current capital position.
Despite the identified deficiencies, Aquestive remains confident in Anaphylm's potential and is actively working to address FDA concerns while advancing global regulatory expansion. The Company's growth strategy and commitment to addressing critical unmet needs in severe allergy management are key focuses moving forward.