Aquestive(US:AQST) Globenewswire·2026-01-09 12:00Core Viewpoint - Aquestive Therapeutics is facing regulatory challenges with the FDA regarding its New Drug Application (NDA) for Anaphylm™, which has identified deficiencies that prevent discussions on labeling and post-marketing commitments, although the review is ongoing and no final decision has been made [2][6]. Regulatory Approval Status - The FDA has notified Aquestive of deficiencies in the NDA for Anaphylm, which the company is working to understand and resolve before the scheduled PDUFA action date of January 31, 2026 [2][3]. - The NDA submission for Anaphylm is supported by a comprehensive clinical development program, including eleven independent clinical studies with approximately 967 total administrations across 411 subjects [3]. Global Expansion Plans - Aquestive is advancing its global expansion strategy for Anaphylm, with plans to submit regulatory approvals in Canada, Europe, and the United Kingdom in 2026 [4][5]. - The company expects to submit its New Drug Submission (NDS) to Health Canada in the first half of 2026 and has received positive feedback from the European Medicines Agency (EMA) indicating no further clinical trials are needed prior to submission [4]. Financial Position - As of December 31, 2025, the company reported approximately $120 million in cash and cash equivalents, which is believed to be sufficient to support the approval and launch processes for Anaphylm in the U.S. and other key markets [6][7]. Product Overview - Anaphylm™ (dibutepinephrine) is a sublingual film designed to be easy-to-use, fast-acting, and portable, representing a significant advancement for individuals with severe allergies [2][8]. - The product is comparable in pharmacokinetic profile to leading epinephrine auto-injectors and has shown a safety profile similar to that of epinephrine [3].