Achieve Life Sciences to Announce Third Quarter Financial Results and Host Conference Call and Webcast on November 6, 2025

Core Insights - Achieve Life Sciences, Inc. is focused on the development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [1][3] - The company will report its Q3 2025 financial results and provide updates on the cytisinicline program on November 6, 2025 [1] - The FDA has accepted Achieve's New Drug Application for cytisinicline, with a PDUFA date set for June 20, 2026 [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company addressing the global smoking health crisis through cytisinicline [3] - Cytisinicline has shown efficacy in two completed Phase 3 studies and an open-label safety study for smoking cessation [3] - The company has also completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA [3] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death [4] - There are around 17 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation [5] - The FDA has recognized the need for treatments in this area by awarding a National Priority Voucher and granting Breakthrough Therapy designation [5] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors to help treat nicotine addiction [6] - The product is still investigational and has not yet received FDA approval for any indication in the U.S. [6]