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Filed: 2026-10-19 AccNo: 0001398733-26-000063 Size: 6 MB Item 5.03: Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year Item 9.01: Financial Statements and Exhibits
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Aquestive Therapeutics announced it will release its financial results for the third quarter ended September 30, 2026, after market close on November 3, 2026, followed by an investor conference call on November 4.
FDA accepted the resubmission as complete and classified it as a Class 2 responsePrescription Drug User Fee Act (PDUFA) goal action date set for March 16, 2027Ex-U.S. strategy remains on track with Canadian NDS planned
Aquestive Therapeutics announced that the FDA has accepted its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for treating Type I allergic reactions and anaphylaxis. The FDA assigned a PDUFA goal date of March 16, 2027, classified as a Class 2 response. If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions. The company is also advancing its Canadian regulatory submission planned for Q4 2026.