Key Points – Anaphylm remains the main focus: Aquestive still plans to resubmit its NDA for the epinephrine sublingual film in Q3 2026, pending FDA feedback on human factors work and other remaining review steps.
The company said it has made progress with U.S. and international regulators and may seek expedited review. – Q1 results improved sharply: First-quarter revenue rose 66% year over year to $14.4 million, while net loss narrowed to $8.1 million from $22.9 million
Reduced SG&A and R&D spending helped drive the better bottom line. – Balance sheet and launch prep strengthened: Aquestive secured a $150 million Oaktree debt facility, which lowers interest costs and improves liquidity ahead of a potential Anaphylm launch. Management said it could have more than $150 million in cash at launch when combined with existing resources and the RTW agreement. Aquestive Therapeutics (NASDAQ:AQST) said it remains on track to resubmit its new drug application for Anaphylm, its epinephrine sublingual film for severe allergic reactions, in the third quarter of 2026, while reporting higher first-quarter revenue and a narrower net loss.
On the company’s first-quarter earnings call, Chief Executive Officer Dan Barber said Aquestive has made “significant” progress since its prior update, including completing a Type A face-to-face meeting with the U.S. Food and Drug Administration, holding a teleconference with the U.K. Medicines and Healthcare products Regulatory Agency, submitting a pediatric investigational plan to the European Medicines Agency and submitting its human factors protocol to the FDA.