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 pharmaceutical company that frequently reports on the progress of its proprietary drug delivery technologies and product candidates. Company news often centers on Anaphylm™ (dibutepinephrine) Sublingual Film, a polymer matrix-based epinephrine prodrug product candidate in late-stage development for severe allergic reactions, including anaphylaxis. Press releases describe clinical data, regulatory milestones, and interactions with the U.S. Food and Drug Administration (FDA) and other regulators.
Investors following AQST news can expect updates on the FDA review of the Anaphylm New Drug Application, including communications about advisory committee decisions, review status, and identified deficiencies, as well as the company’s efforts to address regulatory feedback. Aquestive also issues news about its global regulatory strategy for Anaphylm, such as planned and ongoing submissions in Canada, Europe, and the United Kingdom, and feedback from agencies like Health Canada and the European Medicines Agency.
Beyond Anaphylm, Aquestive’s news flow includes developments in its AdrenaVerse™ epinephrine prodrug platform and the AQST‑108 topical gel program for dermatologic conditions, including alopecia areata. The company regularly reports quarterly financial results, outlines its outlook, and discusses manufacturing and royalty-based revenues from licensed products such as Suboxone® Sublingual Film, Sympazan® Oral Film, Ondif® Oral Film, and Azstarys®.
Additional AQST news items cover patent issuances for Anaphylm and related technologies, leadership changes intended to support clinical and commercial execution, participation in healthcare and investor conferences, and financing transactions linked to future product revenues. Readers interested in AQST news can use this page to monitor regulatory, clinical, financial, and strategic announcements that shape the company’s trajectory.
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.
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.