FDA Accepts Aquestive New Drug Application for Oral Epinephrine

Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Anaphylm, an orally delivered epinephrine treatment for severe allergic reactions, including anaphylaxis, with a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. If approved, Anaphylm would be the first oral epinephrine option in the U.S., offering a needle-free, device-free alternative that is thin, portable, and requires no special storage, potentially improving patient compliance and ease of use. The FDA indicated that an advisory committee meeting might be necessary during the review process, which Aquestive is preparing for. Despite this progress, the company reported financial challenges in early 2025, including missed earnings and revenue forecasts, and faces risks such as declining revenues and high leverage. Analysts remain generally bullish on the stock, with price targets between $4.75 and $15.00, reflecting optimism about the product's potential impact on anaphylaxis care. Experts highlight that Anaphylm addresses major barriers to epinephrine use, such as fear of administration and the inconvenience of carrying bulky devices, which could be transformative for patients at risk of severe allergic reactions.