PharmFilm®
Search documents
Aquestive Therapeutics to Participate in Upcoming March Investor Conferences
Globenewswire· 2026-02-25 12:00
WARREN, N.J., Feb. 25, 2026 (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, announced today that the management team will participate in four upcoming investor conferences in March as follows: TD Cowen 46th Annual Health Care Conference: Management will be available for 1x1 meetings on Tuesday, March 3rdLeerink Pa ...
Aquestive Therapeutics to Participate in Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-23 12:00
WARREN, N.J., Feb. 23, 2026 (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, announced today that the management team will participate in the upcoming Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, which is a virtual event. The Aquestive team will be presenting on February 26th, at 1 ...
Aquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical Officer
Globenewswire· 2026-02-18 12:00
Board-certified allergist and leading food allergy and anaphylaxis researcher joins Aquestive to support Anaphylm™ (dibutepinephrine) sublingual film NDA resubmission and pipeline WARREN, N.J., Feb. 18, 2026 (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 appointment of Matthew Greenhawt, MD, ...
Aquestive Therapeutics Announces Leadership Expansion to Support Growth
Globenewswire· 2025-11-04 12:00
Core Viewpoint - Aquestive Therapeutics is making strategic leadership changes to support the potential launch of Anaphylm™, a novel epinephrine product, and to enhance its development pipeline [1][2][4] Leadership Changes - Dr. Matthew Davis has been appointed as Chief Development Officer, bringing over 20 years of experience in drug development and medical leadership [2][3] - Dr. Gary Slatko returns as interim Chief Medical Officer, with over three decades of experience in regulatory science and drug safety [3] - Peter Boyd has been promoted to Chief People Officer, having led various functions within the company since 2013 [4][5] Product Development - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate designed for the rescue treatment of severe allergic reactions [7] - If approved by the FDA, Anaphylm would be the first oral medication for anaphylaxis, with a unique delivery method that does not require water or swallowing [7] Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products [8] - The company collaborates with pharmaceutical firms to develop new molecules using proprietary technologies like PharmFilm® [8]
Aquestive Therapeutics to Participate in a Fireside Chat Hosted by Piper Sandler
Globenewswire· 2025-11-03 12:00
Core Insights - Aquestive Therapeutics, Inc. is hosting a live fireside chat on November 6, 2025, focusing on its product candidate Anaphylm™ (dibutepinephrine) Sublingual Film, discussing regulatory progress and commercial readiness [1][2] Company Overview - Aquestive Therapeutics is a pharmaceutical company dedicated to improving patients' lives through innovative science and delivery technologies, developing orally administered products to deliver complex molecules [5] - The company has four commercialized products marketed by its licensees globally and collaborates with pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [5] Product Details - Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug that is designed to be administered without water or swallowing, making it user-friendly [4] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis, with its trade name conditionally approved [4]
Aquestive Therapeutics to Attend 2025 ACAAI Annual Meeting
Globenewswire· 2025-10-30 11:00
Core Insights - Aquestive Therapeutics is advancing its product candidate Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, with multiple presentations scheduled at the 2025 ACAAI Annual Meeting [1][2] Company Overview - Aquestive Therapeutics focuses on innovative science and delivery technologies to improve patient lives through the development of orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [4] 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] - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, with its trade name conditionally approved [3]
Aquestive Therapeutics to Report Third Quarter 2025 Financial Results and Recent Business Highlights on November 5 and Host Conference Call on November 6 at 8:00 a.m. ET
Globenewswire· 2025-10-27 11:00
Core Insights - Aquestive Therapeutics, Inc. will report its third quarter results for the period ending September 30, 2025, and provide business updates on November 5, 2025 [1] - A conference call for investors is scheduled for November 6, 2025, at 8:00 a.m. ET, with a live webcast available on the company's website [2] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, aiming to improve patients' lives [3] - The company has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [3] - Aquestive is developing a late-stage proprietary product candidate for severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatological conditions like alopecia areata [3]
Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™
Globenewswire· 2025-09-04 11:00
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].
Aquestive Therapeutics Announces Pricing of $85 Million Underwritten Offering of Common Stock
Globenewswire· 2025-08-14 10:28
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]
Aquestive Therapeutics Announces $75M Strategic Funding Agreement with RTW to Support the Potential Launch of Anaphylm™ (epinephrine) Sublingual Film
GlobeNewswire News Room· 2025-08-14 10:00
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].