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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) 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.
Aquestive Therapeutics will join the Russell 3000 and Russell 2000 Indexes, effective June 28, 2024, following the annual reconstitution of the Russell U.S. indexes. This inclusion highlights the company's achievements over the past year, including the successful completion of a Pivotal Study for Anaphylm (epinephrine) Sublingual Film, which met all primary and secondary endpoints, and FDA approval of Libervant (diazepam) Buccal Film for young epilepsy patients. Additionally, Aquestive raised $77.5 million from institutional healthcare investors. CEO Dan Barber emphasized that this milestone increases the company's visibility, awareness, and liquidity as they prepare for the potential market launch of their products, subject to FDA approval.
Aquestive Therapeutics (NASDAQ: AQST) has announced key executive appointments to boost its leadership team ahead of the anticipated launch of Anaphylm™ (epinephrine) Sublingual Film. Sherry Korczynski joins as Senior VP, Sales and Marketing, bringing over 20 years of experience, including roles at Mylan and ANI Pharmaceuticals. Dr. Stephen Wargacki is promoted to Chief Science Officer, having contributed significantly to the company's epinephrine prodrug platform since joining in 2015. Cassie Jung, with two decades at Aquestive, is named Chief Operating Officer, previously overseeing operations and CNS development. These strategic appointments aim to strengthen Aquestive's commercial capabilities and advance the launch of Anaphylm, potentially the first non-invasive epinephrine treatment for severe allergic reactions, pending FDA approval.
Aquestive Therapeutics will present data on Anaphylm™ (epinephrine) sublingual film at the 2024 Eastern Allergy Conference. The presentations will showcase positive pharmacokinetic and pharmacodynamic data from two clinical studies. The Phase 3 pivotal trial for Anaphylm met all expected endpoints, and the company plans to submit a New Drug Application to the FDA by the end of 2024. The conference will be held from May 30 to June 2 in Palm Beach, Florida, featuring experts in allergy, asthma, and immunology.
Aquestive's CEO Dan Barber expressed optimism about Anaphylm's potential to revolutionize severe allergic reaction treatments. The posters will be presented by Dr. Gary Slatko and Dr. David Golden on May 31.
Aquestive Therapeutics, Inc. (AQST) will participate in The Citizens JMP Life Sciences Conference on May 13, 2024. The management team will hold a fireside chat and host investor meetings. A webcast of the chat will be available on the company's website. For more information, visit investors.aquestive.com.
Aquestive Therapeutics reported positive results for their Phase 3 study on Anaphylm in Q1 2024, aiming for FDA approval by end of 2024. They also received FDA approval for Libervant for patients ages 2-5. The company extended their cash runway into 2026 through a public offering and continues to progress their pipeline development.
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