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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 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.
Aquestive Therapeutics (AQST) announced it will report Q4 and full-year 2020 results on March 9, 2021, after market close. Management will host a conference call for investors on March 10, 2021, at 8:00 a.m. ET. The call can be accessed via phone or live webcast on the company’s investor website. The company focuses on developing differentiated pharmaceutical products addressing unmet patient needs, with its main product being Sympazan, an oral film for treating epilepsy. A forward-looking statement outlines potential risks related to clinical trials and regulatory approvals.
Aquestive Therapeutics (NASDAQ: AQST) announced the appointments of Julie Krop, M.D., and Marco Taglietti, M.D., as new Board members, effective February 10, 2021. Krop is the Chief Medical Officer at Freeline Therapeutics and Taglietti serves as CEO of SCYNEXIS. They join the Board during a pivotal phase for the company, which continues to develop products targeting CNS and allergy markets. The company also noted the resignation of Douglas K. Bratton after 17 years of service. The new directors are expected to enhance strategic direction and clinical development efforts.
Aquestive Therapeutics (NASDAQ: AQST) announced the appointment of Mark Lepore, MD, as Chief Medical Officer for Allergy, emphasizing its focus on the epinephrine delivery program. Dr. Lepore brings over 14 years of drug development experience, previously holding leadership roles at Lupin Pharmaceuticals and Teva Pharmaceuticals. The company is also advancing the resubmission of its Libervant™ (diazepam) Buccal Film application, with expected FDA feedback soon. This strategic leadership addition may strengthen the company’s position in addressing anaphylaxis treatment needs.
Mitsubishi Tanabe Pharma America (MTPA) and Aquestive Therapeutics (AQST) announced a licensing and supply agreement for EXSERVAN™ (riluzole), an oral film for treating ALS. MTPA will commercialize the product in the U.S., with Aquestive as the sole manufacturer. EXSERVAN aims to aid patients with swallowing difficulties. The rollout is planned for mid-2021, with Aquestive receiving upfront fees, milestone payments, and royalties on sales. The oral film utilizes Aquestive's PharmFilm® technology, offering a dissolvable alternative to traditional riluzole tablets.
On January 7, 2021, Aquestive Therapeutics (NASDAQ: AQST) provided updates on its drug candidates Libervant™ and AQST-108. The company resubmitted a revised dosing regimen for Libervant to the FDA, with feedback expected by late January 2021. The NDA resubmission is anticipated in the first half of 2021. AQST-108, an innovative sublingual film delivering epinephrine for anaphylaxis, completed a Phase 1 trial demonstrating consistent delivery and safety. The company plans further clinical studies for AQST-108 in 2021, aiming to enhance its market presence and regulatory approvals.
Aquestive Therapeutics (NASDAQ: AQST) announced management's participation in two upcoming virtual conferences: H.C. Wainwright BioConnect 2021 (January 11-14) and Westwicke Healthcare Day at ICR Conference 2021 (January 14 at 2:30 PM ET). The company will also host one-on-one investor meetings during this week. Webcasts of the discussions will be available on the company's Investor website for 30 days post-event. Aquestive focuses on innovative pharmaceutical solutions, including their proprietary product, Sympazan®, and aims to address unmet medical needs with new drug technologies.
Aquestive Therapeutics (NASDAQ: AQST) announced the resignation of CFO John Maxwell, effective year-end 2020, to pursue other interests. Maxwell joined the company in January 2017 and was instrumental in its evolution into a public pharmaceutical entity. Ernie Toth will succeed him as interim CFO. The company confirmed no operational issues are linked to Maxwell's departure and maintained its 2020 financial outlook. The company specializes in developing innovative therapies, including the commercial product Sympazan and a pipeline targeting central nervous system diseases.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced participation in the Piper Sandler Virtual 32nd Annual Healthcare Conference from December 1-3, 2020. The management team will engage in a fireside chat and hold one-on-one investor meetings on December 2, 2020. A webcast of the chat will be available on the Company's website, with a replay accessible for 30 days post-event. Aquestive focuses on developing differentiated pharmaceutical products addressing unmet patient needs, with a pipeline targeting CNS diseases and innovative drug delivery technologies like PharmFilm®.
Aquestive Therapeutics (NASDAQ: AQST) announced receiving a $10 million milestone payment as part of a royalty monetization agreement with Marathon Asset Management, bringing total proceeds for Q4 to $50 million. The funds will aid in repaying senior notes and support the development of key products, including Libervant™ for managing seizure clusters. The company anticipates up to $75 million in additional milestone payments through mid-2022, contingent upon meeting specific royalty targets.
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