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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 multiple presentations highlighting results from the investigational use of its product candidate Anaphylmâ„¢ (dibutepinephrine) sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting. The meeting will take place November 6-10, 2025, in Orlando, FL.
An oral presentation, titled "Phase 1 Evaluation of Sublingual Film: Pharmacokinetics/Pharmacodynamics Safety Tolerability in at Risk Pediatric Patients," will be presented during the Distinguished Industry & Late Breaking Oral Abstracts session on Saturday, November 9, 2025 by Matthew Greenhawt, MD, MBA, MSc.
Additional poster presentation details are as follows:
Poster Title: Sublingual Epinephrine (Anaphylmâ„¢) Provides Consistent Pharmacokinetics in both Adult and Pediatric Subjects
Lead Author: Nils F. Confer, PhD
Presentation Time: Friday, Nov. 7
Poster Title: Recognizing Unmet Needs in Anaphylaxis Care: Insights from Clinician and Caregiver Surveys
Lead Author: Nils F. Confer, PhD
Presentation Time: Sunday, Nov. 9
The abstracts will be available online at annualmeeting.acaai.org , as well as on the Company's website on the Scientific Events page of the of the Investor section beginning on November 6, 2025.
About Anaphylmâ„¢ (dibutepinephrine) Sublingual Film
Anaphylmâ„¢ (dibutepinephrine) 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 phone or wallet, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. If approved by the Unites States Food and Drug Administration (FDA), Anaphylm would be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis. The Anaphylm trade name for AQST-109 has been conditionally approved by the 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 dermatology 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 Anaphylmâ„¢ (dibutepinephrine) Sublingual Film through clinical development and approval by the FDA; that Anaphylm will be the first and only oral administration of epinephrine and accepted as an alternative to existing standards of care, if Anaphylm is approved 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; regarding the potential benefits our product candidates, including Anaphylm and AQST-108, could bring to patients, if these product candidates are approved by the FDA; and regarding business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are based on the Company's 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, as well as the regulatory approval process through the FDA, including those relating to Anaphylm and AQST-108, or failure to receive approval of these product candidates at all; risk of government shutdown on the ability of the FDA to act on the approval of our product candidates, including Anaphylm and AQST-108; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section and in other sections included in the Company's Annual Report on Form10-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.
Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com
