Core Viewpoint - Aquestive Therapeutics has successfully completed a Type A meeting with the FDA regarding the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, aimed at treating Type 1 allergic reactions, including anaphylaxis [1][2] Group 1: FDA Interaction and Study Design - The Type A meeting confirmed the company's approach on key program elements and received clarifying feedback on pharmacokinetic (PK) and human factors (HF) study designs [2][7] - The FDA provided preliminary comments on the PK study design, focusing on consistency with past studies, and the company plans to address this feedback [2][3] - The FDA recommended changes to user groups in the HF study design, and the company believes there is alignment on key elements following discussions during the meeting [3] Group 2: Product Details and Market Potential - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is designed for easy administration without the need for water or swallowing, making it a unique oral epinephrine rescue medication [5] - The product is expected to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for severe allergic reactions, which could transform treatment options for patients at risk [4][8] Group 3: Future Plans and Regulatory Submissions - The company reaffirms its guidance to resubmit the Anaphylm NDA in the third quarter of 2026 and is also advancing regulatory submissions in Canada and the European Union [4][7] - The company is preparing for human factors and pharmacokinetic studies to support the planned NDA resubmission [2][4]

Core Viewpoint - Aquestive Therapeutics, Inc. has appointed Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer, effective April 2, 2026, succeeding Lori J. Braender, who will remain as Corporate Secretary [1][5] Company Leadership Changes - Thomas A. Zalewski brings extensive experience in life sciences law and has previously served as a Partner and Chair of the Healthcare and Life Sciences practice at Day Pitney LLP [1][2] - Lori J. Braender has served as Chief Legal Officer and Chief Compliance Officer since September 2018 and will continue as Corporate Secretary after her transition [3][5] Compensation and Inducement - Mr. Zalewski will receive an equity award of 100,000 Restricted Stock Units and 75,000 non-qualified common stock options as part of his inducement to join the company [4] - The equity awards will vest over three years, with 25% vesting after the first and second anniversaries, and 50% on the third anniversary [4] Company Overview - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, operating as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) [6] - The company is known for its PharmFilm® technology and is advancing Anaphylm™, the first oral epinephrine rescue medication, towards FDA approval [6]

Core Viewpoint - Aquestive Therapeutics, Inc. announced an inducement grant for Dr. Matthew Greenhawt, Chief Medical Officer, under its 2022 Equity Inducement Plan, approved by the Compensation Committee [1][2]. Group 1: Inducement Grant Details - Dr. Greenhawt will receive 75,000 Restricted Stock Units (RSUs) and 50,000 non-qualified common stock options, with grants scheduled for March 9, 2026 [2]. - The RSUs and Options will vest 25% after the first and second anniversaries of the grant date, and 50% on the third anniversary, contingent on continued employment [2]. - The Options will have a ten-year term with an exercise price equal to the closing price of the common stock on the grant date [2]. Group 2: Company Overview - Aquestive is a pharmaceutical company focused on innovative science and delivery technologies to improve patients' lives [3]. - The company is a leader in delivering medications via oral film and operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) [3]. - It manufactures four commercialized products for licensees globally and has a library of over 20 epinephrine prodrugs for allergy and dermatological indications [3].

分组1 - The company, Aquestive Therapeutics, is advancing medicines to improve patients' lives through innovative science and delivery technologies [2] - It operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) [2] - The company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents [2] 分组2 - The company is advancing Anaphylm™ (dibutepinephrine) sublingual film for severe allergic reactions, including anaphylaxis [2] - AQST-108 (epinephrine prodrug) topical gel is being developed for various dermatological conditions, including alopecia areata [2] - The AdrenaVerse™ platform contains a library of over 20 epinephrine prodrugs for potential allergy and dermatological indications [2] 分组3 - Dr. Greenhawt will receive an equity award of 75,000 Restricted Stock Units and 50,000 non-qualified common stock options under the 2022 Equity Inducement Plan [1] - The equity awards will vest 25% after each of the first and second anniversaries of the grant date, and 50% on the third anniversary [1] - The awards were approved by the independent Compensation Committee as a material inducement for Dr. Greenhawt's acceptance of employment [1]

Core Insights - Aquestive Therapeutics, Inc. is participating in four upcoming investor conferences in March 2026, showcasing its commitment to engaging with investors and stakeholders [1] Company Overview - Aquestive is a pharmaceutical company focused on improving patients' lives through innovative science and delivery technologies [2] - The company is a leader in oral film medication delivery and operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) [2] - Headquartered in New Jersey, the company has U.S.-based manufacturing facilities in Indiana and is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents [2] - The company utilizes proprietary technologies like PharmFilm® and has a library of over 20 epinephrine prodrugs within its AdrenaVerse™ platform, targeting various allergy and dermatological indications [2] Product Development - Aquestive is advancing Anaphylm™ (dibutepinephrine) sublingual film for treating severe allergic reactions, including anaphylaxis [2] - The company is also developing AQST-108 (epinephrine prodrug) topical gel for potential dermatological conditions, including alopecia areata [2] Upcoming Events - Management will be available for one-on-one meetings at the TD Cowen 46th Annual Health Care Conference on March 3rd [6] - A fireside chat is scheduled for March 9th at the Leerink Partners Global Healthcare Conference 2026, with additional one-on-one meetings available [6] - A presentation will take place on March 10th at the Citizens Life Sciences Conference, along with one-on-one meetings [6] - Management will also be available for one-on-one meetings on March 11th at the Barclays 28th Annual Global Healthcare Conference [6]

Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its fourth quarter results for the year ended December 31, 2025, and provide business updates on March 4, 2026, after market close [1] Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on improving patients' lives through innovative science and delivery technologies [3] - The company is a leader in delivering medications via oral film and operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) [3] - It is headquartered in New Jersey with manufacturing facilities in Indiana and is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents [3] - The company utilizes proprietary technologies like PharmFilm and has developed the AdrenaVerse™ platform, which includes over 20 epinephrine prodrugs for various allergy and dermatological indications [3] Product Development - Aquestive is advancing Anaphylm™ (dibutepinephrine) sublingual film for treating severe allergic reactions, including anaphylaxis [3] - The company is also developing AQST-108 (epinephrine prodrug) topical gel for potential dermatological conditions, including alopecia areata [3]

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [3] - The company operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with headquarters in New Jersey and manufacturing facilities in Indiana [3] - Aquestive is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents, utilizing proprietary technologies like PharmFilm® [3] Upcoming Events - The management team will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a presentation scheduled for February 26 at 12 pm ET [1][2] - A webcast of the presentation will be available on the company's website, with a replay accessible for 30 days following the event [2] Product Development - The company is advancing its AdrenaVerse™ platform, which includes a library of over 20 epinephrine prodrugs aimed at various allergy and dermatological indications [3] - Current product developments include Anaphylm™ (dibutepinephrine) sublingual film for severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine prodrug) topical gel for dermatological conditions like alopecia areata [3]

Core Viewpoint - Aquestive Therapeutics announced the investigational use of Anaphylm™ (dibutepinephrine) sublingual film, which achieved clinically relevant epinephrine plasma concentrations without causing a dip in diastolic blood pressure, highlighting its potential to transform anaphylaxis management [1][2]. Group 1: Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact, requiring no water or swallowing for administration [3]. - The product's packaging is designed to be portable and weather-resistant, making it easy to carry in a wallet or phone [3]. - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis [3]. Group 2: Clinical Data and Presentations - Multiple poster presentations at the 2026 AAAAI Annual Meeting will showcase the clinical data for Anaphylm, emphasizing its differentiated profile and potential for meaningful outcomes [2]. - Key findings include the absence of a diastolic blood pressure dip following sublingual administration, which is a significant clinical concern in anaphylaxis treatment [2]. Group 3: Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, operating as both a product developer and a Contract Development and Manufacturing Organization (CDMO) [5]. - The company has a portfolio that includes four commercialized products and a library of over 20 epinephrine prodrugs for various allergy and dermatological indications [5].

Core Viewpoint - Aquestive Therapeutics has appointed Dr. Matthew Greenhawt as Chief Medical Officer to support the resubmission of the Anaphylm™ New Drug Application (NDA) and advance its clinical pipeline [1][2][3] Company Leadership and Expertise - Dr. Greenhawt is an internationally recognized expert in allergy and immunology, bringing extensive clinical, research, and advocacy experience to the company at a critical time [2][4] - The appointment is seen as a strong addition to the leadership team, with Dr. Greenhawt's expertise expected to be invaluable for FDA approval efforts [3] Product Development - Anaphylm™ (dibutepinephrine) is a sublingual film designed for the emergency treatment of anaphylaxis, which is expected to be the first oral medication for severe allergic reactions if approved by the FDA [7] - The product is designed to be user-friendly, dissolving on contact without the need for water or swallowing, and is compact enough to be carried easily [7] Company Background - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, operating as both a product developer and a Contract Development and Manufacturing Organization (CDMO) [8] - The company has a portfolio that includes four commercialized products and is advancing multiple product candidates, including Anaphylm and AQST-108 for various indications [8]

Core Viewpoint - Aquestive Therapeutics, Inc. is actively participating in the Piper Sandler 37th Annual Healthcare Conference, highlighting its commitment to advancing innovative medicines and engaging with investors [1][2]. Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on improving patients' lives through innovative science and delivery technologies, developing orally administered and topical gel products to deliver complex molecules [4]. - The company has four commercialized products marketed by licensees in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [4]. - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatology conditions [4]. Upcoming Events - The management team will hold a fireside chat on December 4, 2025, focusing on the product candidate Anaphylm™ (dibutepinephrine) sublingual film, discussing regulatory progress and commercial readiness [2]. - Investor meetings will also be hosted on the same day, providing opportunities for direct engagement with the management team [2]. Communication and Accessibility - A webcast of the fireside chat will be available on the company's website, with a replay accessible for 30 days post-event [3].