Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a specialty pharmaceutical innovator developing non-invasive therapies for central nervous system disorders and severe allergic reactions. This page serves as the definitive source for official company announcements, regulatory updates, and strategic developments.
Investors and industry stakeholders will find timely updates on product approvals, clinical trial milestones, licensing agreements, and financial performance. Our curated feed includes press releases related to Aquestive’s proprietary PharmFilm® technology, partnership expansions, and advancements in treatments like anaphylaxis management solutions.
All content is organized to provide clear insights into the company’s progress in addressing complex medical needs through innovative drug delivery systems. Key areas of coverage include FDA communications, research breakthroughs, and market expansion initiatives that underscore Aquestive’s role in reshaping patient care paradigms.
Bookmark this page for direct access to primary-source information about AQST’s scientific advancements and corporate strategy. Check regularly for updates that matter to your analysis of this pioneering healthcare company.
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.
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.
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