Achieve Life Sciences Names Dr. Mark Rubinstein Interim Chief Medical Officer

Core Insights - Achieve Life Sciences, Inc. has appointed Mark Rubinstein, M.D. as Interim Chief Medical Officer, succeeding Cindy Jacobs, Ph.D., M.D. [1][3] - The company is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent FDA acceptance of its New Drug Application [3][4] - Cytisinicline is positioned as a potential treatment for the estimated 15 million American adults who attempt to quit smoking each year [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company dedicated to addressing the global nicotine dependence epidemic through cytisinicline [4] - The FDA has set a PDUFA completion date of June 20, 2026, for the cytisinicline New Drug Application [4] - The company has completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [4] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [5] - There are around 17 million adults in the U.S. who use e-cigarettes, and no FDA-approved treatments currently exist specifically for nicotine e-cigarette cessation [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need in nicotine dependence treatment [5][6]