Business
Aquestive Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights
Expects to submit IND application for AQST-108 (epinephrine) in second quarter 2020 and commence pharmacokinetics (PK) clinical trials before end of 2020FDA
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Expects to submit IND application for AQST-108 (epinephrine) in second quarter 2020 and commence pharmacokinetics (PK) clinical trials before end of 2020FDA sets Libervant™ (diazepam) Buccal Film PDUFA goal date of September 27, 2020Reported full year 2019 revenues and adjusted EBITDA that exceeded the top end of guidance rangeConfirms full year 2020 revenue guidance and updates for improved earnings and reduced cash burnHosts investment community conference call at 8:00 am ET on March 12, 2020 WARREN, N.J., March 11, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today reported audited financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on recent developments in its business.\n Keith J. Kendall, Chief Executive Officer of Aquestive, stated, “Significant advancements have been made across our portfolio in 2019 and during the first two months of 2020. We had a constructive pre-IND meeting with the FDA in February 2020 for AQST-108, our “first of its kind” oral sublingual PharmFilm® formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis. Preparations are now underway to file the IND for AQST-108 during the second quarter 2020 and commence PK trials by year end. The ability to pursue a 505(b)(2) regulatory approval pathway for this drug candidate will potentially streamline the development and regulatory process from both a timeline and cost standpoint. If approved, AQST-108, as the first highly portable, easy-to-administer and anxiety-free oral sublingual film medication, is positioned to provide an innovative and transformative treatment for the underserved anaphylaxis patient population for whom the current standard of care is an invasive injection.” “Following the FDA’s acceptance of our NDA in February, our drug candidate, Libervant™ (diazepam) Buccal Film, the first oral diazepam-based therapy for management of seizure clusters, is advancing through the FDA review process and has been assigned a September 27, 2020 PDUFA goal date. We believe that Libervant, if approved by the FDA, will potentially provide a major contribution to patient care to epilepsy pa...