Achieve Life Sciences Promotes Craig Donnelly to Chief Operations Officer

Core Viewpoint - Achieve Life Sciences has promoted Craig Donnelly to Chief Operations Officer to lead the company's operations in preparation for the anticipated launch of cytisinicline, a treatment for nicotine dependence, in mid-late 2026 [1][2][3]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for smoking cessation [4]. - The FDA has accepted the New Drug Application (NDA) for cytisinicline, with a PDUFA completion date set for June 20, 2026 [4]. Leadership and Experience - Craig Donnelly has over 25 years of biopharmaceutical experience, previously serving as Executive Vice President for Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC at Achieve since 2022 [2][3]. - His prior roles include senior positions at NuCana, ICON, and F. Hoffman-La Roche, and he began his career at Pfizer [3]. Product Development - Cytisinicline is a plant-derived alkaloid that interacts with nicotinic acetylcholine receptors to help treat nicotine dependence [7][8]. - The product is currently under development and has not yet received FDA approval for any indication in the United States [8]. Market Need - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally [5]. - 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 [6].