Aquestive Therapeutics Inc

Aquestive Therapeutics plans to resubmit its new drug application for Anaphylm, its epinephrine sublingual film for severe allergic reactions, before the end of the third quarter after revised packaging and instructions substantially reduced errors in validation studies. In the latest human factors study, only one participant had difficulty opening the pouch and none tore the film, compared with 26 and six respectively in the prior study, while administration errors fell from 20 to two. Management assumes a six-month FDA review but will discuss a potential two-month review, and the company is preparing an allergist-focused U.S. launch while expecting to pursue filings in Canada, Europe and the U.K. beginning in the fourth quarter. Second-quarter revenue rose 38% year over year to $13.8 million, adjusted EBITDA loss improved to $5.2 million, and reported net loss widened to $22.9 million largely due to an $11.7 million one-time debt-extinguishment charge. Aquestive maintained full-year 2026 revenue guidance of $46 million to $50 million and expects $75 million in post-approval funding from RTW and $20 million from Oaktree.

The food allergy market across the seven major markets was valued at approximately USD 2.7 billion in 2025 and is projected to expand at a robust CAGR of 9.4% through 2036, according to DelveInsight. The seven major markets comprise the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Key approved therapies include peanut allergen powder (PALFORZIA), omalizumab (XOLAIR), and epinephrine nasal spray (NEFFY). The pipeline features several emerging therapies, including DBV Technologies' Viaskin Peanut Patch in Phase III, Novartis' remibrutinib in Phase II, Aravax's PVX108 in Phase II, GSK's ozureprubart in Phase II, and Aquestive Therapeutics' epinephrine sublingual film ANAPHYLM in Phase III. GSK strengthened its position through the acquisition of RAPT Therapeutics, gaining access to ozureprubart.