Aquestive Therapeutics Says FDA Accepts Resubmitted Filing for Anaphylm in Severe Allergy

MT newswire2026/10/15 11:32

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07:32 AM EDT, 10/15/2026 (MT Newswires) -- Aquestive Therapeutics (AQST) said Thursday that the US Food and Drug Administration has accepted its resubmitted application for Anaphylm sublingual film to potentially treat severe allergic reactions, including anaphylaxis. The agency has set a target action date for March 16, 2027, after classifying the resubmission as a class 2 response, Aquestive said. The company also said it remains on track to submit an application to Health Canada in Q4. Shares of the company were up 1.4% in premarket activity Thursday.

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华尔街见闻•2026/11/08 12:41