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 specialty pharmaceutical innovator developing non-invasive therapies for central nervous system disorders and severe allergic reactions. This page serves as the definitive source for official company announcements, regulatory updates, and strategic developments.
Investors and industry stakeholders will find timely updates on product approvals, clinical trial milestones, licensing agreements, and financial performance. Our curated feed includes press releases related to Aquestive’s proprietary PharmFilm® technology, partnership expansions, and advancements in treatments like anaphylaxis management solutions.
All content is organized to provide clear insights into the company’s progress in addressing complex medical needs through innovative drug delivery systems. Key areas of coverage include FDA communications, research breakthroughs, and market expansion initiatives that underscore Aquestive’s role in reshaping patient care paradigms.
Bookmark this page for direct access to primary-source information about AQST’s scientific advancements and corporate strategy. Check regularly for updates that matter to your analysis of this pioneering healthcare company.
This press release highlights positive feedback from the FDA regarding Aquestive Therapeutics’ AQST-109 epinephrine sublingual film, aimed at treating severe allergic reactions, including anaphylaxis. The FDA's response supports the company’s Chemistry, Manufacturing, and Controls (CMC) approach, aiding future New Drug Application (NDA) filings. An End-of-Phase 2 meeting for clinical feedback is scheduled for later this quarter. The stability of AQST-109 is emphasized, addressing known degradation issues of epinephrine, which enhances its potential market viability.
Aquestive Therapeutics has signed a license and supply agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to treat convulsive seizures across Europe, the UK, and parts of the MENA region. The agreement appoints Aquestive as the exclusive manufacturer, while Pharmanovia manages regulatory and commercialization duties. This deal allows Aquestive to receive upfront and milestone payments, alongside royalties on sales. Libervant offers a unique administration method, improving patient care. The FDA has granted tentative approval for Libervant in the U.S.
Aquestive Therapeutics (NASDAQ: AQST) announced positive topline results from the EPIPHAST II trial for AQST-109, an epinephrine sublingual film. AQST-109 achieved a median time to maximum concentration (Tmax) of 12 minutes, outperforming EpiPen's 22.5 minutes. Repeat dosing showed even faster plasma concentration levels. The company has scheduled a meeting with the FDA for Q4 2022 to discuss further clinical studies. With over 40 million Americans at risk for anaphylaxis, AQST-109 aims to enhance treatment options.
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.
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