Aquestive Therapeutics Stock Price, News & Analysis

Aquestive Therapeutics (NASDAQ: AQST) announced a common stock purchase agreement with Lincoln Park Capital for up to $40 million. This agreement allows Aquestive to sell shares at its discretion over a 36-month term, based on prevailing market prices. The proceeds will support working capital and corporate needs. CEO Keith Kendall expressed that this partnership enhances capital flexibility for the company's growth. Further details will be disclosed in a forthcoming SEC filing. The stock offerings are made under an effective registration statement as of April 5, 2021.

AQST-109, the first orally delivered epinephrine product candidate, shows promising results in the EPIPHAST study. A larger population confirmed rapid absorption with a median time to peak concentration of just 15 minutes, compared to 50 minutes for intramuscular injection. The product is safe and well-tolerated, with no serious adverse events reported. Part 3 of the trial begins this month, and a pivotal PK study is expected in the second half of 2022. The results could significantly enhance the management of severe allergies, including anaphylaxis.

Aquestive Therapeutics (NASDAQ:AQST) announced that the FDA granted Fast Track designation for AQST-109, the first orally delivered epinephrine product for treating allergic reactions, including anaphylaxis. This designation signifies the FDA's acknowledgment of the product's potential to address unmet medical needs. AQST-109 is delivered as a sublingual film, facilitating easier access to emergency medication. The company expects to report topline results from its EPIPHAST study in the first half of 2022 and plans to conduct further meetings with the FDA.

Aquestive Therapeutics (AQST) provided a comprehensive business update, highlighting the ongoing FDA review of its NDA for Libervant™ (diazepam) Buccal Film, designed for epilepsy patients. Following positive results from Part 1 of the EPIPHAST study for AQST-109, an epinephrine oral film, Part 2 has commenced. The company announced a $7 million licensing agreement for riluzole oral film in China and reported Q4 2021 revenues of $11.1 million, a 55% increase year-over-year. Despite a net loss of $28.9 million, Aquestive anticipates strong revenue growth in 2022, projecting total revenues between $42 to $47 million.

Aquestive Therapeutics (NASDAQ: AQST) has signed a License, Development, and Supply Agreement with Haisco Pharmaceutical Group Co., Ltd. for the exclusive commercialization of EXSERVAN™ (riluzole oral film) in China, targeting amyotrophic lateral sclerosis (ALS) treatment. Aquestive will act as the sole manufacturer, receiving a $7 million upfront payment, regulatory milestones, and royalties on sales. EXSERVAN offers ALS patients an alternative delivery method, potentially addressing the swallowing difficulties associated with traditional tablet forms of riluzole.

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.