Aquestive Therapeutics, Inc. 8-K

What Happened

• On March 30, 2026, Aquestive Therapeutics, Inc. (AQST) filed an 8-K (Item 7.01) and issued a press release disclosing that it received preliminary comments and successfully completed an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) related to the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for treatment of Type 1 allergic reactions, including anaphylaxis.

Key Details

• Date filed/announced: March 30, 2026.
• Product: Anaphylm™ (dibutepinephrine) sublingual film — NDA resubmission under discussion with FDA.
• Regulatory event: Completed in-person Type A meeting with FDA and received preliminary FDA comments.
• Filing: Press release attached as Exhibit 99.1 to the 8-K; report signed by CFO A. Ernest Toth, Jr.

Why It Matters

• This disclosure reflects progress in Aquestive’s regulatory interactions for Anaphylm. Receiving FDA feedback and completing a Type A meeting are material steps in the review/resubmission process and can affect timing for potential approval and subsequent commercial milestones.
• The 8-K provides transparency on the company’s regulatory status but does not include new financial results or commitments; investors should watch for follow-up updates on FDA guidance, any required additional data or changes, and new timelines for the NDA resubmission and review.