Aquestive's Anaphylm resubmission accepted, FDA sets March 2027 goal date

Aquestive Therapeutics said on November 3, 2026 that it resubmitted its New Drug Application for Anaphylm to the FDA on September 16, 2026, and the agency acknowledged the resubmission as complete, classified it as a Class 2 response and assigned a PDUFA goal date of March 16, 2027.¹ Outside the U.S., the company expects to submit a New Drug Submission to Health Canada in the fourth quarter of 2026 and plans to file in the European Union in the first quarter of 2027.¹

Anaphylm (dibutepinephrine) is an oral epinephrine product candidate being developed for the treatment of type I allergic reactions, including anaphylaxis.¹ The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA, with final approval of the proprietary name conditioned on FDA approval of the product candidate.¹

For AQST-108, a topical epinephrine prodrug candidate, following completion of a first-in-human study in which no serious or topical adverse events were observed, Aquestive is advancing the program in atopic dermatitis, with additional clinical work expected to begin in the first quarter of 2027.¹

On the Libervant franchise, in October 2026 Aquestive granted Eton Pharmaceuticals exclusive U.S. commercialization rights to Libervant, with Eton handling U.S. commercialization while Aquestive received a $10 million upfront payment, is eligible for up to $47.5 million in milestone payments plus mid-teens royalties, and will remain the exclusive manufacturer under a 20-year supply agreement.¹ Final FDA approval for patients twelve and older depends on expiration of Valtoco's orphan drug exclusivity on January 10, 2027 and a PDUFA goal date of March 23, 2027, while a Type 9 NDA to add patients six to eleven has a PDUFA goal date of March 29, 2027.¹

On financials, cash and cash equivalents were $90.3 million as of September 30, 2026.¹ The company said its full-year 2026 guidance remains unchanged, projecting total revenue of $46 to $50 million and a non-GAAP adjusted EBITDA loss of $35 to $30 million.¹