The FDA decision on Aquestive Therapeutics Inc.’s (AQST) Anaphylm (epinephrine) Sublingual Film, proposed for the emergency treatment of severe allergic reactions, including anaphylaxis, is expected on January 31, 2026.Anphylaxis can develop within minutes after exposure to an allergen, say certain foods, insect stings or bites, or medications. Hives (itchy, raised, red welts) and flushing of the skin, swelling of the throat and tongue, difficulty breathing, wheezing, and coughing, a rapid or weak pulse, low blood pressure, and dizziness or fainting, nausea, vomiting, abdominal pain, and diarrhea are some of the symptoms of anaphylaxis.Epinephrine is the first-line treatment for anaphylaxis and is generally given as an intramuscular (IM) injection, administered by FDA-approved epinephrine auto-injectors like EpiPen, Adrenaclick and Auvi-Q, or a nasal spray like neffy.Aquestive's Anaphylm sublingual film offers several advantages over traditional epinephrine auto-injectors (EAIs), according to the company. If approved by the FDA, Anaphylm would be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis.AQST closed Monday’s (Dec.29, 2025) trading at $6.47, up 8.01%.