Achieve Life Sciences to Present Cytisinicline Data at CHEST 2026

SEATTLE and VANCOUVER, British Columbia, Sept. 28, 2026 /CourierPR/ -- Achieve Life Sciences, Inc., a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, announced today that new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented at CHEST 2026, held October 18-21 in Phoenix, Arizona.

The presentation will feature results from the open-label study, ORCA-OL, which enrolled 475 adults who previously participated in the ORCA-2, ORCA-3, or ORCA-V1 trials and were actively smoking cigarettes and/or vaping daily. Participants received cytisinicline 3 mg three times daily for 52 weeks with behavioral support. The analysis evaluated abstinence throughout the 52-week treatment period, including biochemically verified four-week sustained abstinence and seven-day point prevalence abstinence.

The CHEST 2026 presentation details include: - Presentation Title: Efficacy of 52-Week Cytisinicline Treatment for Cigarette Smoking and E-Cigarette Cessation: The Open-Label ORCA-OL Trial - Session: Top Late-Breaking Abstracts: New Trial Data from Bench to Bronchoscope - Date/Time: Tuesday, October 20, 2026, 2:09-2:13 p.m. MST - Presenter: Mark Rubinstein, MD, Chief Medical Officer, Achieve Life Sciences - Authors: Judith J. Prochaska, PhD, MPH, Stanford University; Neal L. Benowitz, MD, University of California, San Francisco; Dorothy K. Hatsukami, PhD, Masonic Cancer Center, University of Minnesota; Matthew E. Linley, PhD, Achieve Life Sciences; Mark L. Rubinstein, MD, Achieve Life Sciences; Nancy A. Rigotti, MD, Harvard Medical School

Cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor, is believed to aid in treating nicotine dependence for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products.

There are approximately 25 million adults in the United States who smoke combustible cigarettes. Tobacco use is currently the leading cause of preventable death, responsible for more than seven million deaths worldwide and nearly half a million deaths in the United States annually. In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping. In 2025, approximately 1.4 million middle and high school students in the United States reported using e-cigarettes.

Achieve Life Sciences' New Drug Application (NDA) for cytisinicline for smoking cessation in adults is supported by two successfully completed Phase 3 studies and an open-label long-term safety study. The company has also completed a Phase 2 study of cytisinicline in nicotine e-cigarette cessation, conducted an end-of-Phase 2 meeting with the FDA, and has received Breakthrough Therapy designation for the vaping cessation indication.

Forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, all statements other than statements of historical fact, are statements that could be deemed forward-looking statements, including, without limitation, statements regarding the potential benefits of cytisinicline, the potential market for cytisinicline, and the Company's commercialization plans and readiness. Achieve may not achieve its plans, projections, or other expectations and may not be able to successfully complete its NDA resubmission or obtain regulatory approval for cytisinicline on the anticipated timeline or at all.

References ¹Agaku I. Tobacco Product Use among U.S. Adults, 2023-2024, NEJM Evidence, doi: 10.1056/EVIDpha2500339. ²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2025. Geneva: World Health Organization; 2025. ³U.S. Department of Health and Human Services. The Health Consequences of Smoking, 50 Years of Progress. A Report of the Surgeon General. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. ⁴Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use Among Middle and High School Students in the United States: National Youth Tobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116, doi.org/10.1093/ntr/ntag116.