8-K filing — Aquestive Therapeutics, Inc. (AQST)
Filed: 2026-10-15 AccNo: 0001398733-26-000058 Size: 1 MB Item 7.01: Regulation FD Disclosure Item 9.01: Financial Statements and Exhibits
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Eton Pharmaceuticals licenses Aquestive’s LIBERVANT buccal film for U.S. seizure cluster treatment, with launch set for April 2027.
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Filed: 2026-10-15 AccNo: 0001398733-26-000058 Size: 1 MB Item 7.01: Regulation FD Disclosure Item 9.01: Financial Statements and Exhibits
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.
HC Wainwright & Co. analyst Swayampakula Ramakanth reiterates Eton Pharmaceuticals (NASDAQ:ETON) with a Buy and maintains $70 price target.
Filed: 2026-10-14 AccNo: 0001437749-26-032600 Size: 242 KB Item 1.01: Entry into a Material Definitive Agreement Item 2.01: Completion of Acquisition or Disposition of Assets Item 9.01: Financial Statements and Exhibits
Differentiated, portable buccal film would offer patients and caregivers an alternative to existing nasal and rectal seizure rescue treatments, a market opportunity that exceeds $450 million annually in the U.S.Patient