FDA accepts Aquestive's Anaphylm NDA resubmission; PDUFA goal date set for March 16, 2027

Aquestive Therapeutics, Inc.

FDA acknowledged the Anaphylm NDA resubmission as complete and classified it as a Class 2 response, setting a PDUFA goal action date of March 16, 2027.
Aquestive resubmitted September 16, 2026 after August 2026 positive topline human factors and PK study data addressed FDA's January 30, 2026 Complete Response Letter.
Anaphylm (dibutepinephrine) sublingual film targets Type I allergic reactions including anaphylaxis; if approved it would be the first oral rescue medication for severe allergic reactions.
Ex-U.S. strategy on track: New Drug Submission to Health Canada planned for Q4 2026.
CEO Daniel Barber said the acceptance gives 'a clear path forward' and that commercial launch preparations are advancing.

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