Met all endpoints in Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film in first quarter 2024 when compared to EpiPen® and other injectors used for the treatment of anaphylaxisOn track to complete Anaphylm temperature/pH study in second quarter 2024Received positive feedback from FDA on Anaphylm self-administration and allergen exposure protocols; remains on track to complete both studies in third quarter 2024Continues to target filing an Anaphylm New Drug Application (NDA) with the FDA by th ...

Core Insights - The FDA has approved Libervant™ (diazepam) Buccal Film for the treatment of seizure clusters in patients aged 2 to 5, marking it as the first and only orally administered rescue product for this indication [1][2][5] - Libervant is now available in multiple dosages (5mg, 7.5mg, 10mg, 12.5mg, and 15mg) for the target age group [1] - The company has achieved a total of four FDA approvals since 2018, demonstrating a strong track record in regulatory success [1][2] - The Anaphylm™ (epinephrine) Sublingual Film program is on track, with a New Drug Application (NDA) submission expected by the end of 2024 [3] Product Details - Libervant is designed for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity distinct from a patient's usual seizure pattern [1][5] - The buccal film formulation adheres to the buccal mucosa and dissolves quickly, providing a consistent dose of diazepam [2] - In 2023, over 55,000 prescriptions were filled for patients aged 2 to 5, reflecting a 10.8% increase from the previous year [2] Company Overview - Aquestive Therapeutics, Inc. focuses on advancing medicines through innovative science and delivery technologies, with a pipeline aimed at treating central nervous system diseases and severe allergic reactions [13] - The company has five commercialized products marketed globally and collaborates with other pharmaceutical companies to develop new molecules [13] Upcoming Events - The company will host a conference call for investors on April 29, 2024, at 8:00 a.m. ET to discuss the FDA approval and other updates [4]

WARREN, N.J., April 12, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced a poster presentation highlighting the crossover study for the Company’s product candidate, Libervant™ (diazepam) Buccal Film for treatment of children with epilepsy aged two to five, will be presented at the 76th Annual ...

Core Insights - Aquestive Therapeutics, Inc. is presenting a crossover study of its product candidate Libervant™ (diazepam) Buccal Film for treating epilepsy in children aged two to five at the 76th Annual Meeting of the American Academy of Neurology [1][2] - Libervant is designed as an oral alternative to existing device-based treatments for seizure clusters in pediatric patients, aiming to improve patient well-being [2][3] - The FDA has granted tentative approval for Libervant for patients aged 12 and older, with a New Drug Application (NDA) for younger patients currently under review, targeting a PDUFA action date of April 28, 2024 [3][4] Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a pipeline aimed at treating central nervous system diseases and severe allergic reactions [4] - The company has five commercialized products and collaborates with other pharmaceutical companies to develop new molecules using proprietary technologies [4]

Core Insights - Aquestive Therapeutics is approaching a significant milestone with the anticipated topline data readout for their Anaphylm (AQST-109) epinephrine sublingual film, expected in Q1 of this year, with a potential New Drug Application (NDA) filing in 2024 [3][11] - The company announced positive Phase III data in March, showing that Anaphylm matches leading auto-injectors in key endpoints, including a quicker time to maximum concentration (Tmax) [3][7] - Following a $75 million public offering, the stock price has decreased from over $6 to approximately $4 per share, despite the positive Phase III results [3][5] Company Background - Aquestive Therapeutics is a pharmaceutical company focused on developing differentiated products using its proprietary PharmFilm platform, which allows for rapid dissolution of oral film drugs [4][5] - The company has a portfolio of five FDA-approved products and over 150 patents worldwide, with a focus on addressing unmet needs in CNS disorders and anaphylaxis [5][6] Financial Performance - In 2023, Aquestive's total revenues increased from $40 million in 2022 to $50.6 million, representing a 26% rise, while the net loss decreased from $54.4 million in 2022 to $7.9 million in 2023 [5][6] - The company ended 2023 with $23.9 million in cash and projects revenues between $48 million to $51 million for 2024 [6][5] Phase III Results - The Phase III study of Anaphylm met primary and secondary endpoints, demonstrating comparability with leading auto-injectors and a faster Tmax, confirming its potential as a needle-free alternative [7][9] - Anaphylm's exposure levels (AUC) were similar to auto-injectors for up to 30 minutes post-dosing, indicating a sustained therapeutic effect [7][9] Upcoming Catalysts - Upcoming catalysts include a self-administration study and an allergen PK study in Q2, a Pediatric PK study in Q3, and pre-NDA discussions in H2 of this year, all leading up to the NDA submission [11][12] - The NDA submission is expected to be a significant catalyst, marking the start of the FDA review timeline [12][11] Market Potential - Anaphylm has the potential to disrupt the epinephrine auto-injector market, which is projected to exceed $1 billion in peak sales, while Aquestive's market cap is around $370 million [12][13] - Revenue estimates suggest strong double-digit growth for Aquestive, with projections nearing half a billion in revenue over the next decade [12][13]

Aquestive Therapeutics (AQST) ended the recent trading session at $4.14, demonstrating a +0.24% swing from the preceding day's closing price. The stock's change was more than the S&P 500's daily loss of 0.72%. Elsewhere, the Dow saw a downswing of 1%, while the tech-heavy Nasdaq depreciated by 0.95%.Prior to today's trading, shares of the specialty pharmaceutical company had lost 1.2% over the past month. This has lagged the Medical sector's loss of 0.03% and the S&P 500's gain of 2.16% in that time.The inv ...

Company Performance - Aquestive Therapeutics (AQST) closed at $4.38, showing no change from the previous session, outperforming the S&P 500 which lost 0.14% [1] - The stock has increased by 66.54% over the past month, leading the Medical sector's gain of 0.88% and the S&P 500's gain of 5.34% [1] - The upcoming earnings disclosure is anticipated, with an expected EPS of -$0.09, reflecting a 181.82% decline year-over-year, while revenue is projected at $12.47 million, a 12% increase from the previous year [1] Earnings Estimates - Full-year Zacks Consensus Estimates predict earnings of -$0.38 per share and revenue of $50.85 million, indicating year-over-year changes of -192.31% for earnings and +0.52% for revenue [2] - Recent changes in analyst estimates are crucial as they reflect short-term business trends, with upward revisions indicating analysts' positive outlook on the company's operations [2] Zacks Rank and Industry Position - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), shows that AQST currently holds a Zacks Rank of 3 (Hold) [3] - The Medical - Drugs industry, to which AQST belongs, has a Zacks Industry Rank of 145, placing it in the bottom 43% of over 250 industries [3] - The Zacks Industry Rank measures the strength of industry groups, with top-rated industries outperforming the bottom half by a factor of 2 to 1 [3]

Aquestive Therapeutics (NASDAQ:AQST) stock is falling on Wednesday after the pharmaceutical company revealed details of a public offering for its shares.Aquestive Therapeutics is selling 16,666,667 shares of AQST stock for $4.50 each in this public offering. There’s also a 30-day option for underwriters to acquire an additional 2.5 million shares at that same price.Aquestive Therapeutics is expecting $75 million in gross proceeds from the stock offering. The company will use these funds to continue the deve ...

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share. The gross proceeds of the offering to Aquestive, before deducting the underwriting disc ...

Core Viewpoint - Aquestive Therapeutics, Inc. plans to conduct an underwritten public offering of its common stock, with a potential additional 15% of shares available for purchase by underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] - Leerink Partners and Piper Sandler are the joint bookrunning managers, while Oppenheimer & Co. serves as the lead manager for the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the development and commercialization of the product pipeline, including Anaphylm™ Sublingual Film and Libervant™ Buccal Film, as well as for working capital and general corporate purposes [2] Group 3: Company Overview - Aquestive Therapeutics focuses on innovative science and delivery technologies to improve patient lives, with a pipeline that includes treatments for severe allergic reactions and central nervous system diseases [5] - The company has five commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies [5]