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. develops and manufactures specialty pharmaceutical products using proprietary oral-film and drug-delivery technologies. News about AQST centers on the company’s proprietary pipeline, including Anaphylm™ (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and AQST-108, an epinephrine prodrug topical gel being explored for dermatological conditions such as alopecia areata.
Recurring updates also cover FDA interactions and NDA communications for Anaphylm, pharmacokinetic and human-factor study topics, quarterly financial results, licensee and CDMO manufacturing activity, investor presentations, equity inducement grants, and legal, compliance, and board-governance changes.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it will report its fourth-quarter results for 2022 after the market closes on March 7, 2023. The company will also provide an update on recent business developments. Following the announcement, management will host a conference call for investors at 8:00 a.m. ET on March 8, 2023. Interested participants may register in advance for access. This call will be supplemented by a live webcast available on the company’s website. Aquestive focuses on advancing pharmaceuticals to improve patient care, including a late-stage pipeline for central nervous system diseases and early-stage treatments for severe allergic reactions.
Aquestive Therapeutics (NASDAQ: AQST) announced the presentation of four late-breaking posters at the AAAAI annual meeting from February 24-27 in San Antonio, Texas. The posters will showcase positive data from pharmacokinetic and pharmacodynamic studies of AQST-109, a sublingual epinephrine film aimed at treating acute allergic reactions. Dan Barber, CEO, expressed excitement about the data's potential to revolutionize anaphylaxis treatment, pending FDA approval. Notable studies include comparisons between AQST-109 and traditional epinephrine injections, demonstrating faster onset and efficacy parameters. Anaphylaxis poses risks to 49 million Americans, highlighting a significant healthcare need.
Aquestive Therapeutics (AQST) has outlined key initiatives for 2023, focusing on advancing AQST-109 into pivotal trials and pursuing FDA accelerated market access for Libervant™. The company anticipates approximately $27 million in cash as of December 31, 2022. The pivotal pharmacokinetic trial for AQST-109 is expected in the second half of 2023, targeting a potential launch in 2025. With ongoing collaborations and increased manufacturing capabilities, Aquestive aims to enhance its market position and patient outcomes.
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.