Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit
Aquestive Therapeutics (NASDAQ: AQST) announced upcoming presentations of positive data for Anaphylm™, their investigational epinephrine sublingual film, at the CFAAR Food Allergy Summit in Chicago. The presentations will showcase results from pharmacokinetic and pharmacodynamic studies, previously presented at the 2025 AAAAI Annual Meeting.
If approved by the FDA, Anaphylm would become the first and only orally delivered epinephrine treatment for severe allergic reactions in the United States. Two posters will be presented on June 28, 2025, focusing on the drug's physicochemical properties under extreme conditions and its pharmacological responses.
Aquestive Therapeutics (NASDAQ: AQST) ha annunciato le prossime presentazioni di dati positivi riguardanti Anaphylm™, il loro film sublinguale sperimentale di epinefrina, al CFAAR Food Allergy Summit di Chicago. Le presentazioni mostreranno i risultati degli studi farmacocinetici e farmacodinamici, già presentati al Meeting Annuale AAAAI 2025.
Se approvato dalla FDA, Anaphylm diventerebbe il primo e unico trattamento a base di epinefrina somministrato per via orale per le reazioni allergiche gravi negli Stati Uniti. Due poster saranno presentati il 28 giugno 2025, concentrandosi sulle proprietà fisico-chimiche del farmaco in condizioni estreme e sulle sue risposte farmacologiche.
Aquestive Therapeutics (NASDAQ: AQST) anunció próximas presentaciones de datos positivos sobre Anaphylm™, su película sublingual experimental de epinefrina, en la Cumbre CFAAR sobre Alergias Alimentarias en Chicago. Las presentaciones mostrarán resultados de estudios farmacocinéticos y farmacodinámicos, previamente presentados en la Reunión Anual AAAAI 2025.
Si la FDA lo aprueba, Anaphylm sería el primer y único tratamiento de epinefrina administrado por vía oral para reacciones alérgicas graves en Estados Unidos. Se presentarán dos pósteres el 28 de junio de 2025, centrados en las propiedades fisicoquímicas del medicamento bajo condiciones extremas y sus respuestas farmacológicas.
Aquestive Therapeutics (NASDAQ: AQST)는 시카고에서 열리는 CFAAR 식품 알레르기 정상회담에서 그들의 실험용 설하 에피네프린 필름 Anaphylm™에 대한 긍정적인 데이터 발표를 앞두고 있다고 발표했습니다. 이 발표들은 2025년 AAAAI 연례 회의에서 이미 발표된 약동학 및 약력학 연구 결과를 소개할 예정입니다.
FDA 승인을 받으면 Anaphylm은 미국에서 중증 알레르기 반응에 대해 경구 투여되는 최초이자 유일한 에피네프린 치료제가 될 것입니다. 2025년 6월 28일에는 약물의 극한 조건에서의 물리화학적 특성과 약리학적 반응에 초점을 맞춘 두 개의 포스터가 발표됩니다.
Aquestive Therapeutics (NASDAQ : AQST) a annoncé des présentations à venir de données positives concernant Anaphylm™, leur film sublingual expérimental d’épinéphrine, lors du CFAAR Food Allergy Summit à Chicago. Ces présentations mettront en avant les résultats des études pharmacocinétiques et pharmacodynamiques, déjà présentées lors de la réunion annuelle AAAAI 2025.
Si la FDA l’approuve, Anaphylm deviendra le premier et unique traitement à base d’épinéphrine administré par voie orale pour les réactions allergiques sévères aux États-Unis. Deux posters seront présentés le 28 juin 2025, portant sur les propriétés physico-chimiques du médicament dans des conditions extrêmes et ses réponses pharmacologiques.
Aquestive Therapeutics (NASDAQ: AQST) kündigte bevorstehende Präsentationen positiver Daten zu Anaphylm™, ihrem experimentellen epinephrinhaltigen Sublingualfilm, auf dem CFAAR Food Allergy Summit in Chicago an. Die Präsentationen zeigen Ergebnisse aus pharmakokinetischen und pharmakodynamischen Studien, die bereits auf dem AAAAI Jahreskongress 2025 vorgestellt wurden.
Wenn die FDA die Zulassung erteilt, würde Anaphylm die erste und einzige oral verabreichte Epinephrin-Behandlung für schwere allergische Reaktionen in den USA sein. Am 28. Juni 2025 werden zwei Poster vorgestellt, die sich auf die physikochemischen Eigenschaften des Medikaments unter extremen Bedingungen und seine pharmakologischen Reaktionen konzentrieren.
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WARREN, N.J., June 25, 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 two poster presentations highlighting results from the investigational use of Anaphylm™ (epinephrine) Sublingual Film in the treatment of severe allergic reactions, including anaphylaxis, will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit , which will be held June 27-29 in Chicago, Ill. The data from these posters was originally presented at the 2025 AAAAI Annual Meeting. If approved by the U.S. Food and Drug Administration (FDA), Anaphylm would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States.
Poster presentation details are as follows:
Poster Title: The Physicochemical Properties of Anaphylm Under Extreme Temperatures and Real-World Conditions
Lead Author: Nils Confer, PhD
Presentation Time: Saturday, June 28 from 5:00PM to 7:30PM CST
Poster Title: Epinephrine Delivered via Sublingual Film (Anaphylm) Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses
Lead Author: Carl Kraus, MD
Presentation Time: Saturday, June 28 from 5:00PM to 7:30PM CST
The abstracts are available on the Company’s website on the Scientific Events page of the Investors section.
About Anaphylm™ (epinephrine) Sublingual Film
Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the U.S. Food and Drug Administration (FDA). Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for possible various possible dermatological conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn.
Forward-Looking Statement
Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA, including and the following launch of Anaphylm, if approved by the FDA; that the results of the Company’s clinical studies for Anaphylm are sufficient to support submission of the NDA for approval of Anaphylm by the FDA; the advancement of the Company’s product candidate AQST-108 through clinical development and approval by the FDA for possible various dermatology conditions including alopecia areata; the potential benefits our products and product candidates could bring to patients; and business strategies, market opportunities, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including with respect to the approval of our filed NDA for Anaphylm, or the failure to receive FDA approval at all for any of our product candidates, including Anaphylm and AQST-108; risk of the Company’s ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments on the Company’s clinical trials and other concerns identified in the FDA’s Type C meeting minutes and filing review letter for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk that the FDA may require that an Advisory Committee be required for the approval of Anaphylm and that the Company is able to address any concerns raised by such Advisory Committee or the FDA after review of the advice from the Advisory Committee; risk of the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund commercialization activities relating to fund future clinical development and commercial activities for our product candidates, including Anaphylm, should these product candidates be approved by the FDA; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. of Anaphylm and our other product candidates, should these product candidates be approved by the FDA, and for our licensed products in the U.S. and abroad; risk of the size and growth of our product markets; risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office (USPTO); risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and products candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against Aquestive including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and rising interest rates; risks related to the impact of the COVID-19 global pandemic and other pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions; risks related to uncertainties about U.S. government initiatives and their impact on our business, including imposition of tariffs and other trade restrictions; and other unusual items; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.
PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.
Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com
FAQ
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