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.
