SEATTLE and VANCOUVER, British Columbia, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced 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.

CHEST 2026 Presentation Details

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-Adams, Achieve Life Sciences; Mark L. Rubinstein, MD, Achieve Life Sciences; Nancy A. Rigotti, MD, Harvard Medical School

The presentation will feature results from ORCA-OL, an open-label study that 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.

For more information about the conference, visit https://www.chestnet.org/learning-and-events/events/chest-annual-meeting.

About Cytisinicline

There are approximately 25 million adults in the United States who smoke combustible cigarettes.¹ 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.²,³

In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.¹ In 2025, approximately 1.4 million middle and high school students in the United States reported using e-cigarettes.⁴ There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded Achieve the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It 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.

About Achieve Life Sciences, Inc.

Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. Achieve’s 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. Achieve 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

This press release contains 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. These statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including those detailed in Achieve’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Achieve undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

Achieve Contact

Investor Relations

Nicole Jones

ir@achievelifesciences.com

425-686-1510

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.