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. develops and manufactures specialty pharmaceutical products using proprietary oral-film and drug-delivery technologies. News about AQST centers on the company’s proprietary pipeline, including Anaphylm™ (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and AQST-108, an epinephrine prodrug topical gel being explored for dermatological conditions such as alopecia areata.
Recurring updates also cover FDA interactions and NDA communications for Anaphylm, pharmacokinetic and human-factor study topics, quarterly financial results, licensee and CDMO manufacturing activity, investor presentations, equity inducement grants, and legal, compliance, and board-governance changes.
Aquestive Therapeutics (NASDAQ:AQST) has been added to the NASDAQ Biotechnology Index effective December 20, 2021, enhancing its visibility among institutional investors. This inclusion is expected to increase institutional ownership through index fund purchases. The company is anticipating a PDUFDA date for its product Libervant on December 23, 2021, targeting acute seizure treatment. Additionally, AQST-109, an epinephrine delivery film for anaphylaxis, has received FDA feedback confirming its acceptable development pathway, with patient recruitment for studies underway.
Aquestive Therapeutics (AQST) announced significant progress for AQST-109, a treatment for anaphylaxis, receiving FDA confirmation that its 505(b)(2) development pathway is acceptable. The FDA also indicated the potential for Fast Track designation for AQST-109. Additionally, Health Canada has cleared the company to start the EPIPHAST study, with patient recruitment underway. This study will compare the pharmacokinetics of AQST-109 with standard epinephrine injection. The IND filing for AQST-109 is anticipated in early Q1 2022.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. The management team will hold a fireside chat available on demand from November 22, with investor meetings scheduled for November 30. A webcast of the chat will be accessible on the Company's website for 30 days after the event. Aquestive focuses on developing innovative therapies, notably the oral film Sympazan® for central nervous system diseases. For more details, visit investors.aquestive.com.
Aquestive Therapeutics, Inc. (NASDAQ:AQST) reported Q3 2021 financials with total revenues of $13.3 million, up from $8.3 million in Q3 2020. The company improved net loss to $14.6 million or $0.37 per share, versus $16.6 million or $0.49 per share a year ago, driven by increased revenue and lower costs. The firm anticipates FDA feedback on its NDA for Libervant™ by December 23, 2021, and continues development of AQST-109 for allergic reactions, showing promising Phase 1 results. Updated full-year revenue guidance ranges from $47 to $49 million.
Aquestive Therapeutics (NASDAQ: AQST) reported positive results from the Phase 1 clinical trial of AQST-109, an innovative sublingual epinephrine delivery system for anaphylaxis. The study demonstrated a median time to peak concentration (Tmax) of 15 minutes or less, comparable to traditional autoinjectors like EpiPen® and Auvi-Q®. Key clinical measures for safety and efficacy were within expected ranges, with no serious adverse events reported. AQST-109 aims to provide a needle-free alternative, enhancing patient accessibility and safety. A pivotal pharmacokinetic study is anticipated in 2022.
Aquestive Therapeutics (NASDAQ: AQST) has announced it will report its Q3 2021 results on November 2, 2021, after market close. A conference call for investors is scheduled for November 3, 2021, at 8:00 a.m. ET. The company's focus is on developing innovative pharmaceutical products, including Libervant™ (diazepam) Buccal Film. The press release highlights potential risks related to COVID-19's impact on clinical trials, regulatory timelines, and market access. Additionally, the company’s collaboration with other pharmaceutical firms aims to advance drug development.
Aquestive Therapeutics (AQST) announced a bridge waiver agreement with lenders, allowing the deferral of the first principal payment due under its 12.5% Senior Secured Notes to March 30, 2023. This amendment includes a $2.7 million payment to note holders in quarterly installments starting March 30, 2022. CEO Keith Kendall highlighted lender support and the potential for a $30 million debt access upon FDA approval of Libervant, a novel treatment for refractory epilepsy. The FDA has set a PDUFA date of December 23, 2021, for Libervant’s approval.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced participation in three investor conferences in September 2021, aimed at showcasing its innovative pharmaceutical solutions. The events include H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Lake Street Virtual Best Ideas Growth Conference on September 14, and the 2021 Cantor Virtual Global Healthcare Conference on September 30 at 8:00 a.m. ET. Webcast replays will be available for 90 days post-event. For further details, visit investors.aquestive.com.
Aquestive Therapeutics (AQST) announced a $30 million capital access contingent on FDA approval for Libervant, an innovative oral diazepam for managing seizure clusters. The company amended its agreement with lenders, extending the term for six months to June 30, 2022, allowing for a $10 million draw post-FDA approval and an additional $20 million upon U.S. market access. The FDA has set a PDUFA goal date of December 23, 2021, for Libervant's resubmitted NDA. Aquestive remains confident in its non-invasive product's potential, aligning with its broader strategy to address unmet patient needs.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the 12th Annual Wedbush PacGrow Healthcare Virtual Conference on August 11, 2021, at 11:30 am ET. The panel discussion will focus on advancing novel epilepsy targets. The company is known for its innovative pharmaceuticals, including Sympazan®, an oral film for clobazam. It is committed to addressing unmet medical needs through proprietary technologies like PharmFilm®. Forward-looking statements regarding their product Libervant™ highlight potential risks, including regulatory uncertainties and market access challenges.