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

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