Achieve Life Sciences, Inc.

Achieve Life Sciences, Inc. is a specialty pharmaceutical company dedicated to addressing the global smoking health and nicotine addiction epidemic. The company's core mission revolves around the development and commercialization of cytisinicline, a plant-derived alkaloid aimed at helping individuals overcome nicotine dependence. Achieve Life Sciences maintains its primary headquarters in Bothell, Washington, United States, with an additional office located in Vancouver, British Columbia, Canada.

The company's key product is cytisinicline, which functions by binding to nicotine receptors in the brain. This mechanism is designed to reduce withdrawal symptoms and cravings associated with both smoking and vaping cessation. Achieve Life Sciences is actively pursuing the approval of cytisinicline as a novel treatment for nicotine dependence, positioning it to potentially be the first new therapy in this area in two decades.

In April 2026, Andrew D. Goldberg, MD, was appointed as the new Chief Executive Officer. The company also secured significant private placement financing of up to $354 million in April 2026 to support its development and commercialization efforts. Achieve Life Sciences has completed the technology transfer for U.S.-based manufacturing of cytisinicline to Adare Pharma Solutions. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026, for cytisinicline's New Drug Application (NDA) for smoking cessation. While an earlier commercial launch was anticipated, the company now expects a U.S. commercial launch in the first half of 2027, following FDA observations related to manufacturing.