Aquestive operates as both a developer of proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, headquartered in New Jersey with U.S.-based manufacturing in Indiana, and is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents. The company reported approximately $120 million cash as of December 31, 2025 and plans regulatory submissions in Canada, Europe, and the UK in 2026.
Cyborg Score Rationale
Aquestive received a Complete Response Letter from the FDA on January 30, 2026 for Anaphylm™, with deficiencies limited to human factors and a supportive PK study. While the targeted deficiencies are addressable and the company maintains strong cash reserves, execution risk remains high given the company's heavy dependence on this single asset for growth.
Top Insights
The company estimates resubmission in Q3 2026, assuming completion of the HF and PK studies, and plans to request rapid review by the FDA.
If approved by the FDA, Anaphylm would be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis.
Aquestive appointed Dr. Matthew Greenhawt as Chief Medical Officer on February 18, 2026; he is a board-certified allergist with extensive research, advocacy, and editorial experience.
Q3 2025 revenue was $12.8M with net loss of $15.4M; 2025 guidance projects $44–$50M revenue and a non-GAAP EBITDA loss of $47–$51M.
Named Competitors
EpiPen (epinephrine autoinjector) — Established auto-injector for anaphylaxis rescue; incumbent market standard
Auvi-Q (epinephrine autoinjector) — Compact epinephrine autoinjector alternative to EpiPen
Recent Developments
(February 2026) Appointed Dr. Matthew Greenhawt as Chief Medical Officer to support Anaphylm NDA resubmission
(February 2026) Presented clinical data at AAAAI Annual Meeting showing Anaphylm achieved clinically relevant epinephrine concentrations without diastolic blood pressure dip
(January 2026) Received FDA Complete Response Letter on Anaphylm with deficiencies limited to human factors and supportive PK study; targets Q3 2026 resubmission
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