Aquestive Therapeutics, Inc. - AQST STOCK NEWS

On February 28, 2022, Aquestive Therapeutics (NASDAQ: AQST) presented positive topline data from a Phase 1 study of AQST-109, an epinephrine oral film, during the AAAAI annual meeting in Phoenix, Arizona. The study demonstrated that dosing resulted in pharmacokinetic and pharmacodynamic responses within the expected therapeutic range, indicating the potential of AQST-109 as a viable alternative to injection for managing anaphylaxis. The FDA opened the Investigational New Drug Application on February 24, 2022, and the company plans to advance AQST-109 through pivotal studies in 2022.

Aquestive Therapeutics has announced positive topline results from Part 1 of the EPIPHAST study for AQST-109, the first orally delivered epinephrine product. The study demonstrated rapid absorption with a median time to peak concentration (Tmax) of 13.5 minutes. AQST-109 was reported as safe and well tolerated, with no serious adverse events. Part 2 of the trial has commenced, comparing AQST-109 with traditional intramuscular injection methods. The company aims to address challenges faced by patients in managing anaphylaxis.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) has received FDA clearance for its Investigational New Drug Application (IND) for AQST-109, a sublingual film designed for the emergency treatment of severe allergic reactions, including anaphylaxis. The CEO, Keith Kendall, expressed optimism about advancing this therapeutic option. AQST-109 is compact, dissolves quickly, and eliminates the need for water for administration. Anaphylaxis, which has seen a significant increase in hospital admissions, represents a critical market opportunity as the standard treatment currently is epinephrine injection.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) will announce its fourth quarter and full year results for 2021 on March 8, 2022, after market close. The company will hold a conference call on March 9, 2022, at 8:00 a.m. ET. The call will be accessible via phone and also live streamed on the company's website. Aquestive focuses on innovative therapies, with a proprietary product pipeline for central nervous system diseases and partnerships with other pharmaceutical firms. The press release also emphasizes the uncertainties facing the company due to the impact of COVID-19 on its operations and product development.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) will participate in the H.C. Wainwright BioConnect Virtual Conference from January 10 to January 13, 2022. The management team will present on demand during this period and also hold investor meetings. A webcast of the presentation will be accessible via the Company’s Investors section on their website, available for replay for 30 days post-event. The company focuses on developing innovative pharmaceutical products, particularly for CNS diseases, and has commercialized Sympazan®.

Aquestive Therapeutics (NASDAQ: AQST) announced that the FDA has not yet made a decision on the New Drug Application (NDA) for Libervant (diazepam) Buccal Film, intended for treating breakthrough seizures. The FDA's notice indicates regulatory issues are still under consideration, delaying an expected action beyond December 23, 2021. CEO Keith Kendall expressed surprise at the notification and emphasized the company's commitment to working closely with the FDA. Libervant was previously granted Orphan Drug Designation in 2016 and aims to provide non-invasive treatment options for patients with refractory epilepsy.

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.