WARREN, N.J., Oct. 27, 2025 (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 that it will report results for the third quarter ended September 30, 2025 and provide an update on recent developments in its business after market close on Wednesday, November 5, 2025. Management will host a conference c ...

Core Viewpoint - Aquestive Therapeutics has announced that the FDA has determined that an advisory committee meeting is not required for the approval of Anaphylm™ (dibutepinephrine) Sublingual Film, with a target action date set for January 31, 2026 [1][7]. Product Overview - Anaphylm has the potential to be the first FDA-approved, non-invasive, orally delivered epinephrine product for treating severe allergic reactions, including anaphylaxis [2][3]. - The product is designed as a thin, dissolvable film that is placed under the tongue, offering a device-free and needle-free option for patients at risk of severe allergic reactions [2][3]. - Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve upon contact, requiring no water or swallowing for administration [4]. Clinical Development - Eleven clinical studies have been completed, totaling 967 administrations (840 single-dose and 127 repeat-dose) for adults and children over 30 kg [3]. - The development program includes a novel trial for oral allergy syndrome, demonstrating Anaphylm's real-world effectiveness [3]. Company Positioning - The company is well-positioned for the launch of Anaphylm, supported by recent financing activities totaling $160 million, which will facilitate outreach to healthcare providers, caregivers, and patients post-FDA approval [3]. - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, with four commercialized products marketed globally [5].

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [5] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [5] - Currently, Aquestive has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [5] Offering Details - The company announced an underwritten offering of 21,250,000 shares of common stock at a price of $4.00 per share, expecting gross proceeds of $85 million before expenses [1] - The net proceeds will primarily be used to advance the launch and commercialization of Anaphylm™ (epinephrine) Sublingual Film for treating severe allergic reactions, pending FDA approval [1] - The offering is expected to close around August 15, 2025, subject to customary closing conditions [1] Underwriters and Management - The offering was led by RTW Investments, LP, with participation from several investment firms including Samsara BioCapital and EcoR1 Capital [2] - Leerink Partners, Cantor, and Oppenheimer & Co. are acting as joint bookrunning managers, while H.C. Wainwright & Co. is the lead manager [2] Regulatory Information - A shelf registration statement relating to the offering was filed with the SEC and declared effective on April 23, 2024 [3] - A final prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3]

Core Viewpoint - Aquestive Therapeutics has announced a $75 million strategic funding agreement with RTW Investments to support the commercialization of Anaphylm, a sublingual film for emergency treatment of allergic reactions, pending FDA approval [1][2]. Company Overview - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products and a late-stage product candidate for severe allergic reactions [5]. - The company aims to provide novel alternatives to invasive therapies, utilizing proprietary technologies like PharmFilm® [5]. Product Details - Anaphylm™ (epinephrine) Sublingual Film is designed to be a convenient, oral rescue medication for severe allergic reactions, weighing less than an ounce and dissolving on contact without the need for water [4]. - The product's packaging is compact and weather-resistant, making it easy to carry [4]. Funding Agreement - The $75 million funding will be available upon FDA approval of Anaphylm and satisfaction of certain refinancing conditions related to the company's existing debt [2][7]. - RTW Investments will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S., subject to a cap [2]. Strategic Importance - The financing is critical for supporting the company through 2027 and aims to transform how patients access their rescue medication [2]. - RTW Investments expresses confidence in the commercial prospects of Anaphylm as a rescue treatment for severe allergic reactions [2].

Company Overview - Aquestive Therapeutics is a publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines through innovative science and delivery technologies[7] - The company has shipped over 25 billion PharmFilm doses worldwide[10] - Aquestive Therapeutics reported over $57 million in revenue in 2024[13, 14] - The company anticipates 2 product launches in the U S by 2027[17] - The company estimates over $15 billion in potential peak annual net sales from pipeline assets[18] Anaphylm (epinephrine) Sublingual Film - The U S epinephrine market has the potential to grow to approximately $2 billion in value by 2031[54] - The current market size in 2024 is approximately $800 million[55] - The epinephrine market has experienced a 15% CAGR from 2021 to 2023[55, 56] - 95% of patients are interested in a film-dosing option for epinephrine[66] - The PDUFA action date for Anaphylm is scheduled for January 31, 2026[27, 69] AQST-108 (epinephrine) Topical Gel - The company is pursuing alopecia areata (AA) as a potential initial indication for AQST-108[75] - The market opportunity for JAK inhibitors for alopecia areata is estimated at over $1 billion[80]

Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its second quarter results for the period ending June 30, 2025, and will provide updates on recent business developments on August 11, 2025 [1]. Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [3]. - The company is developing orally administered products to deliver complex molecules, offering alternatives to invasive and inconvenient standard therapies [3]. - Currently, Aquestive has four commercialized products marketed by its licensees in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [3]. - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies, such as PharmFilm® [3]. - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an earlier-stage epinephrine prodrug topical gel for various dermatological conditions, including alopecia areata [3]. Upcoming Events - Management will host a conference call for investors on August 12, 2025, at 8:00 a.m. ET, with registration required for participation [2]. - A live webcast of the call will be available on the Investors section of the company's website, and a replay will be archived for 30 days [2].

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [4] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [4] - Currently, Aquestive has four commercialized products marketed by its licensees and collaborates with other pharmaceutical companies to bring new molecules to market [4] Leadership Change - Sherry Korczynski has been promoted from Senior Vice President of Sales and Marketing to Chief Commercial Officer effective July 22, 2025 [1] - Her promotion is attributed to her exceptional track record in commercial leadership, particularly in the allergy market, and her strategic oversight of the EpiPen brand at Mylan [2] - Korczynski joined Aquestive in February 2024 and has over two decades of experience in commercial and launch roles across various pharmaceutical companies [2] Product Development - Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate that is designed to be the first and only device-free, orally delivered epinephrine product [3] - The product is small, weighing less than an ounce, and dissolves on contact without the need for water or swallowing [3] - Anaphylm has been conditionally approved by the U.S. Food and Drug Administration (FDA), with final approval dependent on the product candidate's approval [3] Market Positioning - Anaphylm is positioned to potentially redefine anaphylaxis care, with a focus on successful launch and delivery to patients in the U.S. and abroad [3] - The company aims to leverage Korczynski's deep market knowledge and experience to drive its global commercial strategy for Anaphylm [2]

Core Viewpoint - Aquestive Therapeutics is advancing its regulatory strategy for Anaphylm™ (epinephrine) Sublingual Film, with meetings scheduled with Health Canada and the European Medicines Agency, aiming to provide a needle-free treatment option for anaphylaxis [1][2][4]. Regulatory Strategy - The company has received a meeting with Health Canada to discuss its New Drug Submission for Anaphylm™ and has submitted an initial briefing book to the EMA [1][8]. - A Marketing Authorization Application (MAA) is planned for submission to the EMA as soon as possible [1][2]. Product Overview - Anaphylm™ is an orally administered epinephrine product that addresses issues related to traditional auto-injectors, such as needle phobia and device malfunctions [3][6]. - The product is designed to be portable, weather-resistant, and easy to use, requiring no water or swallowing for administration [6]. Market Focus - The company's ex-U.S. regulatory strategy targets markets with significant unmet medical needs, with Canada and the EMA being prioritized due to their supportive regulatory environments [4][5]. - The company aims to establish Anaphylm as the new standard of care for severe allergic reactions and anaphylaxis globally [5]. Company Background - Aquestive Therapeutics has a portfolio of six FDA-approved drugs and a global presence across six continents, which enhances its ability to navigate international regulatory processes [2][7]. - The company is also developing other product candidates, including a topical gel for dermatological conditions [7].

Core Insights - Aquestive Therapeutics, Inc. announced two poster presentations on Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit, highlighting its potential as the first orally delivered epinephrine option for severe allergic reactions in the U.S. [1] Group 1: Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact without the need for water or swallowing [3] - The product's packaging is designed to be portable and weather-resistant, making it convenient for users [3] - Anaphylm has received conditional approval for its trade name from the FDA, pending final product approval [3] Group 2: Presentation Information - The first poster presentation focuses on the physicochemical properties of Anaphylm under extreme temperatures and real-world conditions, led by Nils Confer, PhD [2] - The second poster presentation discusses the pharmacokinetic and pharmacodynamic responses of Anaphylm, led by Carl Kraus, MD [2] Group 3: Company Overview - Aquestive Therapeutics is dedicated to advancing medicines through innovative science and delivery technologies, with a focus on orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market [4] - In addition to Anaphylm, the company is developing an earlier-stage epinephrine prodrug topical gel for dermatological conditions [4]

Core Viewpoint - Aquestive Therapeutics, Inc. is actively participating in the Citizens Life Sciences Conference, indicating its commitment to engaging with investors and showcasing its innovative pharmaceutical developments [1][2]. Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [3]. - The company is developing orally administered and topical gel products aimed at delivering complex molecules, providing alternatives to traditional therapies [3]. - Currently, Aquestive has four commercialized products marketed by licensees in the U.S. and globally, and it serves as the exclusive manufacturer of these products [3]. - The company collaborates with other pharmaceutical firms to bring new molecules to market using proprietary technologies, such as PharmFilm® [3]. Product Development - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis [3]. - An early-stage epinephrine prodrug topical gel product candidate is also in development for various dermatological conditions, including alopecia areata [3]. Upcoming Events - The management team will hold a fireside chat on May 8 at 10 am ET during the Citizens Life Sciences Conference, along with one-on-one meetings with investors [2]. - A webcast of the fireside chat will be available on the company's website, with a replay accessible for 30 days post-event [2].