Aquestive Therapeutics Stock Price, News & Analysis

Aquestive Therapeutics (NASDAQ: AQST) will report its third-quarter results for the period ending September 30, 2022, on November 1, 2022, post-market. A conference call for investors is scheduled for November 2, 2022, at 8:00 a.m. ET. The company focuses on simplifying drug delivery methods and offers several commercialized products, including Sympazan® for seizure treatment. The company continues to develop products targeting central nervous system diseases and allergic reactions. For additional details, visit their website.

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.