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]

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]

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]

Core Viewpoint - Aquestive Therapeutics has received two additional U.S. patents for Anaphylm, extending its protection until at least 2037, which reinforces its position in the market for treating severe allergic reactions [1][2][7]. Patent Protection - The newly issued patents include U.S. patent number 12,427,121 and U.S. patent number 12,443,850, which cover the proprietary composition for Anaphylm, an epinephrine prodrug sublingual film [2][3]. - These patents are part of a broader intellectual property strategy that includes multiple pending and planned patent applications across various continents [2]. Product Overview - Anaphylm is designed as a device-free, sublingual film that offers a patient-friendly alternative to traditional epinephrine injections, addressing the fear of needles among patients [3][4]. - The product is small, lightweight, and begins to dissolve upon contact, requiring no water or swallowing for administration [4]. Regulatory Timeline - The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is set for January 31, 2026, pending FDA approval [3][6]. Company Background - Aquestive Therapeutics focuses on advancing innovative medicines through proprietary technologies, including PharmFilm and Adrenaverse™, to improve patient care [5]. - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market [5].

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].