Aquestive Therapeutics: FDA sets PDUFA date Mar 16, 2027 for Anaphylm

What happened On Oct 15, 2026, Aquestive Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Mar 16, 2027.

Key details

• The company announced the acknowledgment and PDUFA date in a press release dated Oct 15, 2026.
• Product named: Anaphylm™ (dibutepinephrine) sublingual film.
• PDUFA goal date assigned: Mar 16, 2027.
• The 8-K reports this information under Item 7.01, Regulation FD disclosure.

Why it may matter This filing reports Item 7.01, regulation FD disclosure, which covers public disclosure of material information about the company. A filing does not show why the insider traded or why the company acted.