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) has launched a Scientific Advisory Board composed of eight leading allergy experts to advance its AQST-109 platform. CEO Dan Barber emphasized the board's depth of knowledge will be crucial as the company prepares for pivotal studies and ongoing FDA interactions. Notable members include David Bernstein, Carlos Camargo, and Ruchi Gupta, among others, who collectively hold extensive experience in allergy and immunology. The board aims to provide expert guidance to enhance the development of innovative treatments for severe allergic reactions.
Aquestive Therapeutics, Inc. (Nasdaq: AQST) announced its participation in two investor conferences in September 2022. The company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13 at 4:00 pm ET and will be available for meetings at the Lake Street 6th Annual Best Ideas Growth Conference on September 14. A webcast of the presentation will be accessible on the company's website, with a 30-day replay available. Aquestive focuses on developing innovative orally administered products that improve patient care.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) received tentative FDA approval for Libervant™ (diazepam) Buccal Film, aimed at treating acute seizure clusters in patients with epilepsy aged 12 and older. However, marketing is currently restricted due to the orphan drug exclusivity of Valtoco®, a competing product. Company CEO Daniel Barber expressed optimism about Libervant's potential and plans to engage further with the FDA regarding market access. The company also aims to advance its AQST-109 product for severe allergic reactions.
Aquestive Therapeutics (Nasdaq: AQST) announced key leadership changes, appointing Timothy E. Morris to the Board of Directors and Kenneth Truitt, M.D., as Chief Medical Officer. Morris brings over 35 years of experience in executive leadership and will join the Audit Committee. Truitt, effective September 6, 2022, has over 25 years of clinical experience and aims to advance AQST-109, targeting the emergency treatment of allergic reactions. Both appointments aim to strengthen the company's pipeline and regulatory engagement, particularly with the FDA.
Aquestive Therapeutics reported second quarter 2022 financial results, revealing total revenues of $13.3 million, down from $15.3 million in Q2 2021, despite a 36% surge in revenue from its product Sympazan. The company's net loss widened to $16.3 million or $0.36 per share, compared to a $12.4 million loss, primarily due to increased R&D expenses for AQST-109. However, the firm has updated its full-year revenue guidance to $46-$49 million, up from $42-$47 million, and maintains a positive outlook for its product development and FDA dialogues.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the Wedbush PacGrow Healthcare Conference set for August 9-10, 2022. The management team will host a fireside chat on August 9 at 10:55 am ET and conduct investor meetings until August 10. A webcast of the chat will be available for 30 days on the company's website.
Aquestive focuses on developing innovative orally administered products, including its proprietary Sympazan® for seizures. The company is advancing a pipeline targeting CNS diseases and severe allergic reactions.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it will report its second-quarter results for the period ended June 30, 2022, on August 2, 2022, after market close. Investors can join a conference call on August 3, 2022, at 8:00 a.m. ET, after prior registration. The company focuses on innovative delivery methods for complex molecules and has five commercialized products and a late-stage pipeline targeting central nervous system diseases and severe allergic reactions. For more information, visit Aquestive's website.
Aquestive Therapeutics (AQST) announced positive topline results from Part 3 of the EPIPHAST study for AQST-109, an epinephrine oral film. Key findings showed a consistent Tmax of 12 minutes for sublingual administration after consuming a peanut butter sandwich, with comparable pharmacokinetics to previous datasets. In addition, swallowing the film whole with water resulted in unexpectedly high gastrointestinal absorption, indicating improved compliance potential. The ongoing EPIPHAST II study will compare AQST-109 to standard epinephrine injection methods.
Aquestive Therapeutics (AQST) announced promising results from the EPIPHAST study for AQST-109, an oral film for anaphylaxis treatment. The study demonstrated a median time to maximum concentration (Tmax) of 12 minutes, significantly faster than traditional EpiPen's 50 minutes. AQST-109 shows favorable pharmacokinetics and safety profiles. An upcoming head-to-head study with EpiPen is set for Q3 2022, with plans to seek an End-of-Phase 2 meeting with the FDA shortly thereafter.
Aquestive Therapeutics (NASDAQ: AQST) has completed a registered direct offering, raising approximately $8.5 million by selling 8,850,000 shares at $0.96 each to an institutional investor and $1.09 for its executives. The warrants issued are exercisable after six months at a price of $0.96. CEO Daniel Barber emphasized the focus on profitability and cash generation amidst market challenges, particularly regarding the FDA review of Libervant and the development of AQST-109. The offering is executed under Form S-3 registration with the SEC.
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