Recent Updates — AQST
The U.S. Food and Drug Administration has accepted Aquestive Therapeutics' resubmission of the New Drug Application for Anaphylm (dibutepinephrine) sublingual film as complete. The agency assigned a Prescription Drug User Fee Act goal date of March 16, 2027, classifying the response as Class 2. This follows positive human factors and pharmacokinetic study results submitted in September to address deficiencies from a January 2026 Complete Response Letter. If approved, Anaphylm would be the first oral rescue medication for severe allergic reactions. Aquestive Therapeutics is a biopharmaceutical company advancing medicines through innovative science and delivery technologies.
Aquestive Therapeutics granted Eton Pharmaceuticals exclusive U.S. commercialization rights to LIBERVANT (diazepam) buccal film for the acute treatment of seizure clusters, receiving a $10 million upfront license fee. The agreement includes potential regulatory and commercial milestone payments totaling up to $47.5 million and mid-teens percentage royalties on net sales. Aquestive will serve as the exclusive manufacturer under a 20-year supply agreement. Eton anticipates a commercial launch in April 2027, subject to final FDA approval for patients aged 12 and older, with an additional application pending for ages 6-11. Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative science and delivery technologies.
Aquestive Therapeutics filed an 8-K to furnish an investor presentation dated September 23, 2026. The filing discloses that the company resubmitted its New Drug Application for Anaphylm (dibutepinephrine) sublingual film on September 17, 2026, addressing deficiencies from a January 30, 2026 Complete Response Letter. Aquestive intends to request expedited FDA review and projects a potential commercial launch in 2027 with over $1 billion in annual revenue. The presentation highlights a cash position of $98.5 million as of June 30, 2026, alongside access to up to $95 million in contingent funding upon Anaphylm approval. The company also outlined pipeline progress for Libervant and AQST-108. Aquestive Therapeutics operates in the pharmaceutical industry, developing innovative drug delivery technologies and commercializing medicines.
Aquestive Therapeutics announced the resubmission of its New Drug Application to the U.S. Food and Drug Administration for Anaphylm, a sublingual film for treating Type I allergic reactions including anaphylaxis. The resubmission addresses deficiencies from a January 2026 Complete Response Letter by incorporating revised packaging that reduced median pouch-opening time from 17 seconds to 3 seconds and confirmed pharmacokinetic data in healthy volunteers. No protocol-defined use errors were observed during self-administration studies supporting the filing. Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative oral film delivery technologies.