Achieve Life Sciences Reports Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program

Core Insights - Achieve Life Sciences, Inc. has received FDA acceptance for its New Drug Application (NDA) for cytisinicline, targeting a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2026, for smoking cessation treatment [2][5][13] - The FDA awarded cytisinicline the Commissioner's National Priority Voucher for vaping cessation, highlighting its potential as the first FDA-approved therapy for nicotine dependence related to vaping [2][7][15] - Recent post hoc data published in Thorax indicates that cytisinicline significantly improves smoking quit rates in adults with chronic obstructive pulmonary disease (COPD) [4][8] Company Developments - Achieve Life Sciences has made significant advancements in its cytisinicline development program, including the completion of key clinical trials and safety updates [4][9] - The company appointed Erik Atkisson as Chief Legal Officer, enhancing its leadership team as it prepares for regulatory review and potential commercialization [10] - Financial results as of September 30, 2025, show cash and cash equivalents of $48.1 million, with total operating expenses of $14.7 million for the third quarter [11][21] Market Context - Approximately 60% of the 17 million adult e-cigarette users in the U.S. express a desire to quit, indicating a significant unmet medical need for effective cessation therapies [2][15] - Cytisinicline is positioned as a potential first-in-class treatment for vaping cessation, addressing a growing public health concern [7][15] - The tobacco use landscape includes around 29 million adults in the U.S. who smoke combustible cigarettes, with tobacco being the leading cause of preventable death [14][15]