Aquestive Therapeutics Resubmits NDA for Anaphylm; Files Form 8‑K

What Happened

• Aquestive Therapeutics, Inc. announced on September 17, 2026 (Form 8‑K) that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for Anaphylm™ (dibutepinephrine) sublingual film, intended to treat Type I allergic reactions including anaphylaxis.
• The company also furnished a Regulation FD investor presentation that was given at the H.C. Wainwright 28th Annual Global Investor Conference on September 14, 2026. The press release and presentation were attached to the 8‑K as Exhibits 99.1 and 99.2, respectively.

Key Details

• Filing date of Form 8‑K: September 17, 2026.
• Product: Anaphylm™ (dibutepinephrine) sublingual film — for Type I allergic reactions, including anaphylaxis.
• Investor presentation delivered at H.C. Wainwright conference on September 14, 2026 (attached as Exhibit 99.2).
• Press release announcing NDA resubmission dated September 17, 2026 (attached as Exhibit 99.1).

Why It Matters

• The NDA resubmission is a material regulatory milestone: investors should view it as progress in Aquestive’s effort to gain FDA approval for Anaphylm, which would expand the company’s commercial product potential in emergency allergy treatment.
• The Form 8‑K provides the company’s official disclosure of the resubmission and the investor presentation; investors should monitor subsequent FDA communications and future company filings for review timelines, approval decisions, or additional regulatory updates.