Aquestive Therapeutics Inc
NASDAQ:AQST
Aquestive Therapeutics Inc
Aquestive Therapeutics, Inc. engages in the identifying, developing, and commercializing differentiated products to address unmet medical needs and to solve patients’ therapeutic problems. The company is headquartered in Warren, New Jersey and currently employs 157 full-time employees. The company went IPO on 2018-07-25. The firm is engaged in developing orally administered products to deliver molecules, providing alternatives to care therapies. The company is engaged in advancing a late-stage product pipeline focused on treating diseases of the central nervous system (CNS), and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. The firm's CNS portfolio, which is focused on epilepsy includes Sympazan and Libervant. The active programs in its complex molecule pipeline portfolio are: AQST-109-SF, AQST-108-SF, and AQST-108-SF. Its PharmFilm technology develops medicines that offer non-invasive delivery, customized suitability for patients with dysphagia, or trouble swallowing, can be administered without water and ensures consistent therapeutic dosing. PharmFilm is comprised of polymer compositions that serve as film formers to hold active pharmaceutical ingredients (APIs) and excipients in place.
Aquestive Therapeutics, Inc. engages in the identifying, developing, and commercializing differentiated products to address unmet medical needs and to solve patients’ therapeutic problems. The company is headquartered in Warren, New Jersey and currently employs 157 full-time employees. The company went IPO on 2018-07-25. The firm is engaged in developing orally administered products to deliver molecules, providing alternatives to care therapies. The company is engaged in advancing a late-stage product pipeline focused on treating diseases of the central nervous system (CNS), and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. The firm's CNS portfolio, which is focused on epilepsy includes Sympazan and Libervant. The active programs in its complex molecule pipeline portfolio are: AQST-109-SF, AQST-108-SF, and AQST-108-SF. Its PharmFilm technology develops medicines that offer non-invasive delivery, customized suitability for patients with dysphagia, or trouble swallowing, can be administered without water and ensures consistent therapeutic dosing. PharmFilm is comprised of polymer compositions that serve as film formers to hold active pharmaceutical ingredients (APIs) and excipients in place.
Anaphylm Readiness: Aquestive is fully prepared for a first quarter 2026 launch of Anaphylm, pending FDA approval by the scheduled January 31, 2026 action date.
Financing Secured: The company completed $85 million in equity and $75 million in commercial launch financing, supporting operations through 2027 and the Anaphylm launch.
FDA Review on Track: Management reported no impact from competitor actions or FDA staffing changes, and expects an on-time review with no Advisory Committee meeting required.
Revenue Guidance Unchanged: Full year 2025 revenue expected to be $44–50 million; non-GAAP adjusted EBITDA loss guidance remains at $47–51 million.
Market Growth & Demand: The epinephrine market grew nearly 9% last quarter, with most growth in auto-injectors; strong interest from allergists in Anaphylm's profile.
International Expansion: Positive Health Canada feedback clears path for Canadian filing in first half 2026, with European regulatory interactions ongoing.
Base Business Stable: Stable cash flow from Indivior and growth from South American partnerships continue to support operations.
