Aquestive (AQST) Soars as FDA Speeds Review for Epinephrine Film
Regulator waives advisory committee meeting for Anaphylm, a novel needle-free allergy treatment, boosting investor confidence.
Shares of Aquestive Therapeutics (NASDAQ: AQST) surged more than 12% following a significant regulatory update for its lead drug candidate, Anaphylm, a first-in-class oral film for treating severe allergic reactions.
The U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for review, a critical step toward commercialization. More significantly, the agency has now indicated that it will not require an advisory committee (AdCom) meeting to discuss the application. This development, seen by many as a major de-risking event, signals a potentially smoother path to approval for the innovative treatment.
, with the company's stock trending sharply upwards. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, which investors will be watching closely as the next major catalyst.
Anaphylm is designed to be a groundbreaking alternative to current epinephrine auto-injectors, such as the EpiPen. As an orally administered film that dissolves in the mouth, it offers a device-free and needle-free solution for patients experiencing anaphylaxis. This convenience could be a game-changer for patient accessibility and adherence, removing the fear and hesitation often associated with injections.
The initial was a key milestone, but the decision to forgo an AdCom meeting has amplified optimism. Typically, the FDA convenes these meetings to gain independent expert advice on complex or novel drug applications. Waiving this requirement suggests the agency may have a clear path to evaluating the drug's safety and efficacy based on the data submitted.
Wall Street has taken note of the decreased regulatory risk. Following the announcement, several analysts reiterated their confidence. LifeSci Capital, for instance, initiated coverage with an 'Outperform' rating, while Oppenheimer raised its price target, reflecting a . As Aquestive moves toward its 2026 PDUFA date, the progress of Anaphylm will remain a central focus for the biotech sector.