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 (AQST) announced a successful End-of-Phase 2 meeting with the FDA regarding AQST-109, a sublingual film for severe allergic reactions. The FDA indicated that efficacy studies may not be necessary, instead favoring a comparability study. The guidance emphasizes pharmacokinetic performance aligned with existing injectable epinephrine products. Aquestive aims for a New Drug Application (NDA) submission in the first half of 2024 and anticipates a product launch in 2025.
Aquestive Therapeutics (NASDAQ: AQST) announced the publication of a peer-reviewed study in Epilepsia revealing that food significantly impacts the absorption of diazepam nasal spray. Conducted in 2021, the study showed that, under fed conditions, the mean maximum plasma diazepam concentration decreased by 48%, and overall exposure in the first four hours reduced by 57% compared to fasting. This may imply reduced efficacy of the nasal spray when taken after meals, posing potential implications for patient care and treatment guidelines.
Aquestive Therapeutics, Inc. (Nasdaq: AQST) announced participation in two upcoming investor conferences. The management team will present at the Piper Sandler 34th Annual Healthcare Conference on November 30 at 1:50 PM ET and will be available for meetings at A.G.P.’s Virtual Biotech Conference on December 1. A webcast of the presentation will be available on the Company's investor website for 30 days. Aquestive focuses on simplifying complex drug delivery methods and has developed products for severe allergic reactions and central nervous system diseases.
Aquestive Therapeutics (NASDAQ: AQST) announced it will present three abstracts detailing positive outcomes from pharmacokinetic studies of AQST-109 (epinephrine sublingual film) at the ACAAI Annual Scientific Meeting in Louisville, KY, from November 10-14. The highlights include findings on the formulation and dosage of AQST-109, which aims to improve treatment for acute allergic reactions. The studies, presented by Dr. John Oppenheimer and Holly Ponichtera, emphasize AQST-109's potential benefits and its minimal interactions with food and temperature.
Aquestive Therapeutics reported promising results from its EPIPHAST II trial for AQST-109, showing quicker absorption than EpiPen and intramuscular injection. The company is set for an End-of-Phase 2 meeting with the FDA in Q4 2022. Financially, it generated over $25 million in near-term funding, with third-quarter revenue at $11.5 million, down from $13.3 million year-over-year. Net loss improved to $12.5 million with an adjusted EBITDA loss of $7.7 million. The company confirmed full-year revenue guidance of $46 to $49 million and is exploring out-licensing opportunities for Libervant.
Aquestive Therapeutics (NASDAQ: AQST) has licensed its Sympazan® (clobazam) oral film to Otter Pharmaceuticals, a subsidiary of Assertio Holdings, for $9 million. This transaction allows Aquestive to focus on developing AQST-109, an epinephrine sublingual film. The deal includes a long-term supply agreement and the potential for a $6 million milestone payment upon patent allowance extending coverage to 2039. CEO Daniel Barber highlighted the agreement as a non-dilutive financing option.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced the U.S. District Court for the Eastern District of Pennsylvania dismissed all claims against the company in the Suboxone antitrust lawsuit. This ruling, made on October 19, 2022, reinforces that Aquestive should not have been included in the lawsuit. CEO Daniel Barber expressed optimism about the court's decision and emphasized the company's focus on progressing its pipeline, particularly its leading product, AQST-109, aimed at treating severe allergic reactions, including anaphylaxis.
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.