Core Insights - Achieve Life Sciences, Inc. has approved stock option grants for five new employees as part of its 2024 Equity Inducement Plan, totaling 161,000 shares of common stock [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [4] - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a PDUFA date set for June 20, 2026 [4] - Cytisinicline is being developed for smoking cessation in adults, supported by two completed Phase 3 studies and an open-label safety study [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, highlighting a significant market for cessation products [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need for e-cigarette cessation treatments [5][6]

Core Insights - Achieve Life Sciences announced new data showing that cytisinicline significantly improves smoking quit rates in adults with and without chronic obstructive pulmonary disease (COPD) compared to placebo [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [6] - The FDA has accepted Achieve's New Drug Application for cytisinicline, with a target action date of June 20, 2026 [5][6] Clinical Data - The publication in Thorax presents a post hoc analysis of over 1,600 participants from the ORCA-2 and ORCA-3 trials, highlighting the efficacy and safety of cytisinicline in individuals with self-reported COPD [2][3] - Cytisinicline demonstrated statistically significant increases in continuous smoking abstinence for both COPD and non-COPD subgroups, with quit rates for COPD participants comparable to those without COPD [3] Health Impact - Nearly 16 million U.S. adults have been diagnosed with COPD, with 6 million currently smoking; quitting smoking is crucial for improving health outcomes in this population [4] - Approximately 80% of COPD deaths are attributed to smoking, emphasizing the need for effective cessation tools like cytisinicline [4] Future Developments - Achieve has completed a Phase 2 trial for cytisinicline in vaping cessation and has received Breakthrough Therapy designation from the FDA for this indication [5][8]

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]