Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company that frequently reports on the progress of its proprietary drug delivery technologies and product candidates. Company news often centers on Anaphylm™ (dibutepinephrine) Sublingual Film, a polymer matrix-based epinephrine prodrug product candidate in late-stage development for severe allergic reactions, including anaphylaxis. Press releases describe clinical data, regulatory milestones, and interactions with the U.S. Food and Drug Administration (FDA) and other regulators.
Investors following AQST news can expect updates on the FDA review of the Anaphylm New Drug Application, including communications about advisory committee decisions, review status, and identified deficiencies, as well as the company’s efforts to address regulatory feedback. Aquestive also issues news about its global regulatory strategy for Anaphylm, such as planned and ongoing submissions in Canada, Europe, and the United Kingdom, and feedback from agencies like Health Canada and the European Medicines Agency.
Beyond Anaphylm, Aquestive’s news flow includes developments in its AdrenaVerse™ epinephrine prodrug platform and the AQST‑108 topical gel program for dermatologic conditions, including alopecia areata. The company regularly reports quarterly financial results, outlines its outlook, and discusses manufacturing and royalty-based revenues from licensed products such as Suboxone® Sublingual Film, Sympazan® Oral Film, Ondif® Oral Film, and Azstarys®.
Additional AQST news items cover patent issuances for Anaphylm and related technologies, leadership changes intended to support clinical and commercial execution, participation in healthcare and investor conferences, and financing transactions linked to future product revenues. Readers interested in AQST news can use this page to monitor regulatory, clinical, financial, and strategic announcements that shape the company’s trajectory.
Aquestive Therapeutics (NASDAQ:AQST) announced that the FDA granted Fast Track designation for AQST-109, the first orally delivered epinephrine product for treating allergic reactions, including anaphylaxis. This designation signifies the FDA's acknowledgment of the product's potential to address unmet medical needs. AQST-109 is delivered as a sublingual film, facilitating easier access to emergency medication. The company expects to report topline results from its EPIPHAST study in the first half of 2022 and plans to conduct further meetings with the FDA.
Aquestive Therapeutics (AQST) provided a comprehensive business update, highlighting the ongoing FDA review of its NDA for Libervant™ (diazepam) Buccal Film, designed for epilepsy patients. Following positive results from Part 1 of the EPIPHAST study for AQST-109, an epinephrine oral film, Part 2 has commenced. The company announced a $7 million licensing agreement for riluzole oral film in China and reported Q4 2021 revenues of $11.1 million, a 55% increase year-over-year. Despite a net loss of $28.9 million, Aquestive anticipates strong revenue growth in 2022, projecting total revenues between $42 to $47 million.
Aquestive Therapeutics (NASDAQ: AQST) has signed a License, Development, and Supply Agreement with Haisco Pharmaceutical Group Co., Ltd. for the exclusive commercialization of EXSERVAN™ (riluzole oral film) in China, targeting amyotrophic lateral sclerosis (ALS) treatment. Aquestive will act as the sole manufacturer, receiving a $7 million upfront payment, regulatory milestones, and royalties on sales. EXSERVAN offers ALS patients an alternative delivery method, potentially addressing the swallowing difficulties associated with traditional tablet forms of riluzole.
On February 28, 2022, Aquestive Therapeutics (NASDAQ: AQST) presented positive topline data from a Phase 1 study of AQST-109, an epinephrine oral film, during the AAAAI annual meeting in Phoenix, Arizona. The study demonstrated that dosing resulted in pharmacokinetic and pharmacodynamic responses within the expected therapeutic range, indicating the potential of AQST-109 as a viable alternative to injection for managing anaphylaxis. The FDA opened the Investigational New Drug Application on February 24, 2022, and the company plans to advance AQST-109 through pivotal studies in 2022.
Aquestive Therapeutics has announced positive topline results from Part 1 of the EPIPHAST study for AQST-109, the first orally delivered epinephrine product. The study demonstrated rapid absorption with a median time to peak concentration (Tmax) of 13.5 minutes. AQST-109 was reported as safe and well tolerated, with no serious adverse events. Part 2 of the trial has commenced, comparing AQST-109 with traditional intramuscular injection methods. The company aims to address challenges faced by patients in managing anaphylaxis.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) has received FDA clearance for its Investigational New Drug Application (IND) for AQST-109, a sublingual film designed for the emergency treatment of severe allergic reactions, including anaphylaxis. The CEO, Keith Kendall, expressed optimism about advancing this therapeutic option. AQST-109 is compact, dissolves quickly, and eliminates the need for water for administration. Anaphylaxis, which has seen a significant increase in hospital admissions, represents a critical market opportunity as the standard treatment currently is epinephrine injection.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) will announce its fourth quarter and full year results for 2021 on March 8, 2022, after market close. The company will hold a conference call on March 9, 2022, at 8:00 a.m. ET. The call will be accessible via phone and also live streamed on the company's website. Aquestive focuses on innovative therapies, with a proprietary product pipeline for central nervous system diseases and partnerships with other pharmaceutical firms. The press release also emphasizes the uncertainties facing the company due to the impact of COVID-19 on its operations and product development.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) will participate in the H.C. Wainwright BioConnect Virtual Conference from January 10 to January 13, 2022. The management team will present on demand during this period and also hold investor meetings. A webcast of the presentation will be accessible via the Company’s Investors section on their website, available for replay for 30 days post-event. The company focuses on developing innovative pharmaceutical products, particularly for CNS diseases, and has commercialized Sympazan®.
Aquestive Therapeutics (NASDAQ: AQST) announced that the FDA has not yet made a decision on the New Drug Application (NDA) for Libervant (diazepam) Buccal Film, intended for treating breakthrough seizures. The FDA's notice indicates regulatory issues are still under consideration, delaying an expected action beyond December 23, 2021. CEO Keith Kendall expressed surprise at the notification and emphasized the company's commitment to working closely with the FDA. Libervant was previously granted Orphan Drug Designation in 2016 and aims to provide non-invasive treatment options for patients with refractory epilepsy.
Aquestive Therapeutics (NASDAQ:AQST) has been added to the NASDAQ Biotechnology Index effective December 20, 2021, enhancing its visibility among institutional investors. This inclusion is expected to increase institutional ownership through index fund purchases. The company is anticipating a PDUFDA date for its product Libervant on December 23, 2021, targeting acute seizure treatment. Additionally, AQST-109, an epinephrine delivery film for anaphylaxis, has received FDA feedback confirming its acceptable development pathway, with patient recruitment for studies underway.