Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence [3] - The company has successfully completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation [3] - Achieve plans to submit its new drug application for smoking cessation in Q2 2025 and has conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor, aimed at treating nicotine addiction for both smoking and e-cigarette cessation [6] - The product is believed to reduce the severity of nicotine craving symptoms and the reward associated with nicotine products [6] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the critical need for e-cigarette cessation treatments [5] Market Context - Approximately 29 million adults smoke combustible cigarettes in the U.S., with tobacco use being the leading cause of preventable death, responsible for over eight million deaths worldwide annually [4] - There are over 11 million adults in the U.S. who use e-cigarettes, with 1.6 million middle and high school students reporting e-cigarette use in 2024 [5] - Currently, there are no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation [5]
Achieve Life Sciences to Present at the Oppenheimer Healthcare Life Sciences Conference