Aquestive Therapeutics Resubmits Anaphylm NDA to FDA

07:26 AM EDT, 09/17/2026 (MT Newswires) -- Aquestive Therapeutics (AQST) said Thursday that it resubmitted its New Drug Application to the FDA for Anaphylm, a sublingual film for treating Type I allergic reactions, including anaphylaxis. The resubmission follows the FDA's January Complete Response Letter requesting additional human factors and confirmatory pharmacokinetic studies, it said. Aquestive said the completed studies support revised packaging and instructions for use, reducing median pouch-opening time to three seconds from 17 seconds. The company said it plans an allergist-focused launch if Anaphylm is approved.