Business
Aquestive Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Submitted NDA for Anaphylm™ (epinephrine), the first and only oral sublingual film for patients with severe allergic reactions Advancing commercial readiness
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Submitted NDA for Anaphylm™ (epinephrine), the first and only oral sublingual film for patients with severe allergic reactions Advancing commercial readiness efforts with a planned Q1 2026 launch of Anaphylm, subject to FDA approvalCompany to host investor call on May 13, 2025, at 8:00am ET WARREN, N.J., May 12, 2025 (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 announced financial results for the first quarter ended March 31, 2025, and provided a strategic business update. “In the first quarter of 2025, we achieved a major milestone for Aquestive with the submission of the NDA for Anaphylm,” said Daniel Barber, President and Chief Executive Officer of Aquestive. “This represents a critical step toward delivering the first oral, non-invasive epinephrine treatment for patients experiencing severe allergic reactions, including anaphylaxis. We anticipate receipt of FDA's determination of acceptance of our NDA submission in the second quarter of 2025 and our full team is actively preparing for a potential U.S. launch in the first quarter of 2026, if approved by the FDA. We continue to gain enthusiasm from all of our expanding pre-commercial efforts for Anaphylm, as we believe that we are the potential best-in-class epinephrine therapy in a multi-billion dollar growing market. Going forward we will have complete focus on our pre-commercial preparedness and the FDA approval process for Anaphylm. From now until post-launch, we will de-emphasize other activities such as the advancement of AQST-108, and we will not appeal the court decision on Libervant. This will focus resources, both people and financial, towards the upcoming launch of Anaphylm, if approved by the FDA.\" Anaphylm™ (epinephrine) Sublingual FilmAquestive has completed the submission of its New Drug Application (NDA) for Anaphylm with the U.S. Food and Drug Administration (FDA). The NDA includes data from the full adult clinical program and the recently completed pediatric study. Topline results from the pediatric trial in patients aged 7 to 17 demonstrated a pharmacokinetic (PK) profile consistent with prior adult clinical data, supporting a proposed label aligned ...