Business
Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update
Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives confirmation from
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives confirmation from FDA that Agency’s review of Anaphylm NDA application is ongoing and no final FDA decision has been madeProgresses global regulatory expansion activities in Canada, Europe, and the United Kingdom for AnaphylmUnaudited cash and cash equivalents of approximately $120 million as of December 31, 2025 WARREN, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (\"Aquestive\" or the \"Company\"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today provided an update on the regulatory approval of Anaphylm™ and its business. “As part of its ongoing review of the Company’s NDA for Anaphylm, the FDA notified us that it had identified deficiencies in the NDA that preclude discussion of labeling and post-marketing commitments at this time,” said Dan Barber, President and Chief Executive Officer of Aquestive. “Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns. The FDA stated that the notification does not reflect a final decision on the pending application and the FDA’s review remains ongoing.” “While we await further information from the FDA, we remain confident about Anaphylm and its potential to be the first and only FDA-approved sublingual film,” continued Mr. Barber. “Designed to be easy-to-use, fast-acting, and highly portable, we continue to believe Anaphylm represents a major step forward for people living with severe allergies. We are advancing our global expansion of Anaphylm with plans to submit for regulatory approval in Canada, Europe, and the United Kingdom in 2026. We believe our long-term growth strategy remains compelling with the potential approval and subsequent launch of Anaphylm in the U.S. and around the world. With the recent equity raise and our current cash position, we also believe that we have the necessary capital to execute on our current growth strategy.” Anaphylm™ (dibutepinephrine) Sublingual Film The Company is in contact with the U.S. Food and Drug Administration (FDA) to gather further information about the deficiencies presently identified by the FD...