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) provided a business update and outlined key objectives for 2025. The company reported unaudited cash and cash equivalents of approximately $70 million as of December 31, 2024.
Key developments include: planned submission of Anaphylm™ (epinephrine) Sublingual Film NDA in Q1 2025, ongoing pediatric clinical trial recruitment, and successful completion of AQST-108 topical gel pre-IND meeting with FDA clearance to begin Phase 2a trial for alopecia areata in Q2 2025.
The company received FDA approval and Orphan Drug Exclusivity until April 2031 for Libervant®, the first FDA-approved oral rescue treatment for seizure clusters in pediatric patients aged 2-5 years. Aquestive's 2025 strategy focuses on Anaphylm's potential U.S. launch in Q1 2026, expanding ex-U.S. development, conducting AQST-108 trials, growing Libervant sales, and transitioning from legacy products to growth opportunities.
Aquestive Therapeutics announced that the U.S. FDA has granted Orphan Drug Exclusivity (ODE) to Libervant® (diazepam) Buccal Film for pediatric patients aged 2 to 5 with seizure clusters. The ODE provides seven years of market exclusivity in the United States, extending until April 2031. Libervant, approved on April 26, 2024, offers a non-invasive, orally administered rescue therapy for acute repetitive seizures, providing a significant improvement over rectal administration.
Daniel Barber, CEO of Aquestive, emphasized the importance of this treatment in providing ease of use for patients and caregivers. The FDA's decision acknowledges the major contribution of Libervant's buccal route to patient care. The Orphan Drug Designation, initially granted on November 10, 2016, supports the development of treatments for rare diseases, offering financial incentives and market exclusivity upon regulatory approval.
Libervant is the first and only FDA-approved orally administered rescue product for this patient population.
Aquestive Therapeutics (NASDAQ: AQST) received positive FDA feedback regarding its planned NDA submission for Anaphylm™, a potential first-ever orally delivered epinephrine product for severe allergic reactions treatment. The FDA agreed with the company's planned NDA content, format, safety evaluation, and pediatric trial design, which has begun in the U.S. and Canada. The company reaffirmed its NDA submission timeline for Q1 2025, with no additional adult clinical trials required. The FDA indicated a possible advisory committee meeting due to the novel route of administration. Anaphylm aims to serve an estimated 33 million Americans with food allergies who currently rely on epinephrine medical devices.
Aquestive Therapeutics (NASDAQ:AQST) has announced its participation in two major healthcare investor conferences. The company will attend the Jefferies London Annual Healthcare Conference from November 19-21, 2024, offering one-on-one meetings with management. Additionally, they will participate in Piper Sandler's 35th Annual Healthcare Conference on December 4th, 2024, featuring a fireside chat at 1:30 PM ET and one-on-one meeting opportunities.
The Piper Sandler presentation will be webcast and available on the company's website under the 'Events and Presentation' section, with replay access for 30 days post-event.
Aquestive Therapeutics (NASDAQ:AQST) reported Q3 2024 financial results with total revenues of $13.5 million, up 4% from Q3 2023. The company reported a net loss of $11.5 million ($0.13 per share). Key developments include positive topline data from the OASIS study for Anaphylm™, their oral epinephrine treatment, with a pre-NDA meeting scheduled for Q4 2024. The company maintains $77.9 million in cash and expects a cash runway into 2026. Full-year 2024 guidance projects revenue of $57-60 million with a non-GAAP adjusted EBITDA loss of $20-23 million.
Aquestive Therapeutics (NASDAQ: AQST) announced a subsequent analysis of their pivotal study for Anaphylm™ (epinephrine) Sublingual Film to be presented at the ACAAI 2024 Annual Meeting. The analysis demonstrates that the film maintains consistent pharmacokinetics and pharmacodynamics regardless of placement or movement in the mouth.
The study showed that 87.5% of subjects had no change in film location between 1.5 to 3 minutes after administration. In cases where movement occurred (12.5% of subjects), there were no significant differences in drug concentration metrics. The geometric mean maximum concentration was 351.14 and 490.27 pg/mL for subjects with and without film movement, respectively, with a median peak drug concentration of 12 minutes for both groups.
Aquestive Therapeutics (NASDAQ: AQST) announced positive topline results from its Oral Allergy Syndrome (OAS) challenge study for Anaphylm™ sublingual film. The study met both primary and secondary endpoints, demonstrating rapid symptom resolution beginning two minutes after administration. The median time for complete symptom resolution was twelve minutes, significantly faster than the 74-minute baseline. The pharmacokinetic profile remained consistent with previous studies, showing a 12-minute time to maximum plasma concentration. The company plans a pre-NDA meeting with FDA in Q4 2024, aims to submit an NDA in Q1 2025, and targets product launch in Q1 2026.
Aquestive Therapeutics (NASDAQ: AQST) hosted a virtual investor day highlighting its Adrenaverse™ epinephrine prodrug platform, focusing on two key products: Anaphylm™ (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel. The company announced:
1. Completion of enrollment in the oral allergen challenge study for Anaphylm™
2. Plans to submit a New Drug Application (NDA) for Anaphylm™ in Q1 2025
3. Development strategy for AQST-108 to treat Alopecia areata
4. Completion of the first human clinical study for AQST-108
Aquestive aims to hold a pre-NDA meeting with the FDA in Q4 2024 for Anaphylm™ and plans a full product launch, if approved, by end of 2025 or Q1 2026. For AQST-108, the company expects to hold a pre-IND meeting with the FDA in Q1 2025 and commence a Phase 2 study in H2 2025.
Aquestive Therapeutics (NASDAQ: AQST) has announced a virtual investor day scheduled for September 27, 2024, at 8:00 am ET. The event will focus on pipeline updates, particularly for two key products: Anaphylm™ (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel. Both are candidate products from the company's Adrenaverse™ epinephrine prodrug platform.
The presentation will feature Aquestive's management team and a guest speaker, Dr. J. David Farrar, Associate Professor of Immunology/Molecular Biology at UT Southwestern Medical Center. Investors can register for the event online, and a webcast will be available for 30 days after the presentation on the company's investor relations website.
Aquestive Therapeutics (NASDAQ: AQST) has announced its participation in two upcoming investor conferences in September 2024. The company will present at the H.C. Wainwright 26th Annual Global Investor Conference on September 9th at 8:30 am ET and host investor meetings. Additionally, Aquestive will be available for investor meetings at the Lake Street BIG8 Conference on September 12th.
A webcast of the H.C. Wainwright presentation will be accessible on the company's website under the "Events and Presentation" page in the Investors section. The webcast replay will remain available for 30 days after the event. Aquestive Therapeutics is a pharmaceutical company focused on developing innovative medicines and delivery technologies to improve patients' lives.