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Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a specialty pharmaceutical company dedicated to developing and commercializing innovative medicines designed to solve critical healthcare challenges. By focusing on patient-centric solutions, Aquestive aims to improve the lives of individuals managing complex diseases. The company's core area of expertise lies in the Central Nervous System (CNS) and severe allergic reactions, including anaphylaxis.
Core Business and Products
Aquestive Therapeutics leverages its proprietary drug delivery technologies to create novel oral treatments that offer convenient alternatives to invasive, conventional therapies. The company’s commercial product portfolio includes:
- Sympazan Oral Film - A treatment for seizures associated with Lennox-Gastaut Syndrome.
- Suboxone Sublingual Film - Utilized in opioid addiction management.
- Exservan Oral Film - A medication for Amyotrophic Lateral Sclerosis (ALS).
- Zuplenz - An antiemetic to prevent nausea and vomiting.
Pipeline and Recent Developments
Aquestive's robust pipeline includes late-stage candidates such as:
- Libervant Buccal Film - Positioned to address seizure clusters in epilepsy patients.
- AQST-108 - A sublingual film for the treatment of anaphylaxis.
- AQST-305 - A developing solution for severe allergic reactions.
The company has made significant strides with its proprietary PharmFilm® technology, enhancing drug delivery effectiveness and patient compliance. Aquestive collaborates with other pharmaceutical entities to bring these advanced treatments to market. Recent achievements include pivotal trials and regulatory submissions that underscore the company's commitment to addressing unmet medical needs.
Financial Overview
Aquestive Therapeutics predominantly earns its revenue from the United States through product sales and licensing agreements. The company’s latest financial reports indicate stable growth prospects, driven by its innovative product offerings and strong pipeline.
Partnerships and Market Presence
Aquestive actively partners with leading pharmaceutical firms to expand its reach and impact. The company's collaborations enable the development and commercialization of breakthrough treatments, further establishing its presence in the global pharmaceutical landscape.
For more information, recent updates, and investor inquiries, please visit the company’s official website or contact their investor relations team.
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.
Aquestive Therapeutics (NASDAQ: AQST) has commented on the FDA's recent approval of the first non-injection-based epinephrine device for treating severe allergic reactions, including anaphylaxis. The company views this as a positive development for patients seeking alternatives to needle-based epinephrine delivery. Aquestive is developing its own product, Anaphylm™ (epinephrine) Sublingual Film, which could potentially become the first oral epinephrine treatment for anaphylaxis.
Aquestive reiterates its timeline for Anaphylm™, expecting to file a New Drug Application (NDA) with the FDA in Q1 2025. The company anticipates a full product launch, if approved, by late 2025 or early 2026. Currently, Aquestive is conducting its final supportive study, the oral allergy syndrome (OAS) challenge, expected to conclude in late Q3 or early Q4 2024.
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