Aquestive climbs after US FDA says no advisory panel needed for epinephrine film

Aquestive Therapeutics

04/09/2025 15:54

Updates

** Shares of Aquestive Therapeutics AQST.O rise 14.7% to $4.53

** Drug developer says the FDA does not plan to hold an advisory committee meeting for its epinephrine film, Anaphylm

** The FDA will decide on approval for Anaphylm by January 31, 2026

** Anaphylm is a small, dissolvable film placed under the tongue that delivers epinephrine without needles or devices

** If approved, it could be the first FDA-approved, non-invasive, oral epinephrine option for severe allergic reactions (including anaphylaxis), the company says

** The company has run 11 clinical studies with 967 total administrations in adults and children over 30 kg, including a study suggesting effectiveness in treating oral allergy syndrome

** Including session's move, AQST stock up 35.3% YTD

 (Reporting by Padmanabhan Ananthan)

 ((Padmanabhan.Ananthan@thomsonreuters.com))