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

Aquestive Therapeutics

04/09/2025 12:46

** Shares of drug developer Aquestive Therapeutics AQST.O rise 8.9% to $4.30 premarket

** Aquestive says the FDA does not plan to hold an advisory committee meeting for its epinephrine film, Anaphylm, and has set approval date of 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

** Up to last close, AQST stock up ~11% YTD

(Reporting by Padmanabhan Ananthan)

((Padmanabhan.Ananthan@thomsonreuters.com))