Recent Updates — AQST
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.
Aquestive Therapeutics reported second quarter 2026 financial results, posting total revenues of $13.8 million compared to $10.0 million in the prior year period. The company recorded a net loss of $22.9 million, or $0.18 per share, driven largely by an $11.7 million one-time loss on the extinguishment of its 13.5% Notes. Excluding this non-cash charge, the adjusted net loss was $11.2 million. The firm completed required human factors and pharmacokinetic studies for Anaphylm, reaffirming plans to resubmit the New Drug Application to the FDA in Q3 2026. Cash and cash equivalents stood at $98.5 million as of June 30, 2026. Aquestive Therapeutics operates in the pharmaceutical industry, developing proprietary drug delivery technologies and manufacturing products for licensees.
Aquestive Therapeutics announced positive topline results from human factors and pharmacokinetic studies for Anaphylm™ (dibutepinephrine) sublingual film, supporting its planned resubmission of a New Drug Application to the FDA in the third quarter of 2026. The revised packaging reduced median time to open the pouch from 17 seconds to 3 seconds and decreased incorrect film placement by over 80% compared to previous studies. Pharmacokinetic data showed self-administration results comparable to clinician-administered doses, with a geometric mean Cmax of 391.7 pg/mL versus 357.6 pg/mL. The company plans to address deficiencies identified in a January 2026 Complete Response Letter regarding user interface and administration errors. Aquestive Therapeutics is a pharmaceutical company specializing in oral film delivery technologies for prescription drugs.