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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, Inc. (NASDAQ: AQST) has resubmitted its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film to the FDA for managing seizure clusters. This follows a Complete Response Letter (CRL) received on September 25, 2020. The company anticipates a six-month review process, with the PDUFA goal date expected in late 2021. Libervant aims to provide a non-invasive alternative to the current standard of care, Diastat, which is often difficult to administer. The resubmission is considered a significant milestone in bringing this innovative treatment to patients in need.
Aquestive Therapeutics (NASDAQ: AQST) has announced that A. Ernest Toth, Jr. has transitioned from interim Chief Financial Officer to permanent Senior Vice President and CFO, effective immediately. Toth, who joined the company in December 2020, has extensive experience in financial leadership across various healthcare sectors. His appointment is expected to enhance the company's financial operations, with the management expressing confidence in his capability to foster key external relationships.
Aquestive Therapeutics (NASDAQ: AQST) will participate in two investor conferences in June. The management team will host a fireside chat at the JMP Securities 2021 Life Sciences Conference on June 16 at 2:30 pm ET, followed by a rare disease panel at BMO Capital Market 2021 Biopharma Day on June 22 at 10:15 am ET. Investors can access a recorded webcast of the fireside chat for 30 days post-event on the company's website. Aquestive focuses on developing innovative therapeutics to address unmet patient needs.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the 2021 RBC Capital Markets Global Healthcare Conference via a virtual fireside chat on May 19, 2021, at 9:45 ET. The management team will also engage in one-on-one investor meetings during the event. A webcast of the chat will be accessible on the Company’s website, with replay available for 30 days post-event. Aquestive focuses on developing innovative products addressing unmet medical needs, with their pipeline targeting central nervous system treatments.
Aquestive Therapeutics (NASDAQ:AQST) reported first quarter 2021 financial results, showing total revenues of $11.1 million, a 26% increase from $8.8 million in Q1 2020. The company's net loss reduced to $14.7 million ($0.41/share) from $16.5 million ($0.49/share) the previous year. Key developments include plans to refile the Libervant NDA by Q2 2021, launch of a Phase 1 study for AQST-109, and continued growth in Sympazan sales, which rose 56% year-over-year. The full year 2021 financial outlook remains unchanged, targeting revenues of $38 million to $42 million.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) will report its first-quarter results for the period ending March 31, 2021, on May 4, 2021, after market close. A conference call for investors is scheduled for 8:00 a.m. ET on May 5, 2021. The company focuses on developing innovative products addressing unmet patient needs, with its Sympazan® oral film already commercialized. The firm is advancing several product candidates, including Libervant™, while navigating challenges posed by the COVID-19 pandemic.
Aquestive Therapeutics (AQST) recently provided a comprehensive update on its drug delivery program for systemic epinephrine during an R&D event. The company discussed results from two completed Phase 1 pharmacokinetic (PK) trials for AQST-108, a sublingual film candidate, demonstrating promising absorption and conversion profiles. Additionally, the development strategy for AQST-109, another epinephrine prodrug, was outlined. The company seeks patent protection for both candidates until at least 2037, indicating a strong intellectual property position.
Aquestive Therapeutics (AQST) reported financial results for Q4 and full year 2020, revealing total revenues of $7.1 million in Q4, down from $16.4 million in Q4 2019, and $45.8 million for the full year, compared to $52.6 million in 2019. The net loss widened to $20.4 million in Q4 2020 from $12.6 million the previous year. The company expects a 2021 revenue outlook of $38 million to $42 million. Key developments include the pending resubmission of the NDA for Libervant by Q2 2021 and a licensing agreement for EXSERVAN with Mitsubishi Tanabe Pharma.
Aquestive Therapeutics (NASDAQ: AQST) announced it will hold a virtual investor and analyst event on March 25, 2021, focusing on epinephrine drug delivery. The event will present data from two Phase 1 PK trials and the development strategy, featuring insights from experts including Dr. David Fleischer and Dr. John Oppenheimer. Attendees can join the event via webcast or by phone. The webcast will be archived for 30 days. Aquestive is committed to addressing unmet medical needs through innovative drug delivery solutions.
Aquestive Therapeutics (NASDAQ: AQST) announced plans to resubmit its New Drug Application (NDA) for Libervant™ by the end of Q2 2021 after receiving further FDA guidance. This feedback includes expectations for a revised weight-based dosing regimen and safety data for their diazepam buccal film intended to manage seizure clusters. Following a Complete Response Letter in September 2020, the company expects no further clinical trials will be necessary. The anticipated FDA review period post-resubmission is around six months.
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