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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 (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.
Aquestive Therapeutics (NASDAQ:AQST) reported its Q2 2024 financial results and shared business updates. Key highlights include:
- Anaphylm™ (epinephrine) Sublingual Film remains on track for FDA submission in early 2025, with a potential launch by late 2025 or early 2026.
- Positive topline pharmacokinetic (PK) and pharmacodynamic (PD) data reported, showing no significant differences based on temperature and pH variability.
- Libervant™ (diazepam) Buccal Film expanded for ages two to five, with national retail distribution expected by Q4 2024.
- Q2 2024 revenue surged 52% to $20.1 million, up from $13.2 million in Q2 2023.
- Net loss decreased to $2.7 million from $5.8 million in Q2 2023, with non-GAAP adjusted EBITDA income at $1.8 million.
- Cash reserves stand at approximately $90 million, with a cash runway extending into 2026.
An investor call is scheduled for August 7, 2024, at 8:00 am ET.
Aquestive Therapeutics (NASDAQ: AQST) reported positive topline data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film. The study met primary endpoints, showing comparable pharmacokinetics whether administered by subjects or healthcare providers. Key findings include:
1. No statistical difference between self-administered and HCP-administered Anaphylm
2. Median time to maximum concentration (Tmax) was 15 minutes for Anaphylm vs. 50 minutes for Adrenalin IM injection
3. Oral Allergy Syndrome challenge study currently enrolling, expected to complete in Q3/Q4 2024
4. Company anticipates requesting pre-NDA meeting before end of Q3
5. Full product launch projected for late 2025 or Q1 2026
Aquestive Therapeutics (NASDAQ: AQST) has announced it will report its second quarter 2024 financial results and provide a business update after market close on August 6, 2024. The company, which focuses on developing innovative pharmaceutical delivery technologies, will host a conference call for investors at 8:00 a.m. ET on August 7, 2024. Interested parties can register in advance to obtain call-in details. A live webcast will be available on Aquestive's website, with a replay accessible for 30 days following the call in the Investors section of the company's website.
Aquestive Therapeutics (NASDAQ: AQST) announced its participation in the Leerink Partners Therapeutics Forum: I&I and Metabolism on July 9, 2024. The event will feature panels discussing key therapeutic themes in immunology, inflammation, and metabolism. The management team of Aquestive will also host investor meetings during the forum. This participation underscores Aquestive's commitment to advancing innovative medicines that significantly improve patients' lives.
Aquestive Therapeutics announced positive topline pharmacokinetic (PK) data from their temperature and pH study of Anaphylm, a sublingual film for treating severe allergic reactions.
The study found that the PK results of Anaphylm were not affected by oral cavity exposure to liquids of different temperatures and pH. Cmax and AUC ratios were consistent across various test conditions, indicating reliable drug performance.
Aquestive remains on track to complete supportive studies and plans to request a pre-NDA meeting with the FDA in Q3 2024, with an NDA filing planned post-pediatric study completion.
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