Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026

The study followed adults receiving yearlong treatment, but its abstinence findings have not yet been disclosed.

Rhea-AI Summary

Achieve Life Sciences (ACHV) will present cytisinicline cessation data from the ORCA-OL trial at CHEST 2026 on October 20.

The open-label study enrolled 475 adults who had participated in earlier ORCA trials and were smoking cigarettes and/or vaping daily. They received 3 mg of cytisinicline three times daily for 52 weeks, along with behavioral support. The analysis assessed abstinence during treatment, including biochemically verified four-week sustained abstinence and seven-day point prevalence abstinence. The announcement did not include the efficacy results.

Key Figures

Study enrollment: 475 adults Cytisinicline dose: 3 mg three times daily Treatment duration: 52 weeks +2 more

Study enrollment

475 adults

ORCA-OL open-label study

Cytisinicline dose

3 mg three times daily

With behavioral support

Treatment duration

52 weeks

ORCA-OL treatment period

Sustained abstinence endpoint

4-week

Biochemically verified abstinence

Point prevalence abstinence endpoint

7-day

Analysis measure

Key Terms

open-label, biochemically verified, point prevalence abstinence, new drug application (nda), +2 more

6 terms

open-label medical

"an open-label study that enrolled 475 adults"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

biochemically verified medical

"including biochemically verified four-week sustained abstinence"

Confirmation by laboratory tests that a reported biological state or behavior (for example, drug use, smoking abstinence, or presence of a biomarker) is true, based on measurable molecules, metabolites, or physiological markers rather than on self-report. Like showing a receipt instead of relying on someone's word, biochemical verification gives objective evidence that clinical results or compliance claims are real, which matters to investors because it affects the credibility, regulatory acceptance, and commercial value of medical or consumer-health claims.

point prevalence abstinence medical

"seven-day point prevalence abstinence"

A measure used in clinical trials that records whether a participant has been abstinent from a substance (commonly tobacco) during a short, specified window immediately before a study visit — for example, no use in the past 7 or 30 days. It is a snapshot, like a photo taken at one appointment, and may be based on self-report or biochemical tests; investors use it to gauge a treatment’s reported short-term effectiveness and to compare results across studies.

new drug application (nda) regulatory

"Achieve’s New Drug Application (NDA) for cytisinicline"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

breakthrough therapy designation regulatory

"granted Breakthrough Therapy designation to address this critical need"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

nicotinic acetylcholine receptor medical

"high binding affinity to the nicotinic acetylcholine receptor"

A nicotinic acetylcholine receptor is a protein on the surface of nerve or muscle cells that acts like a lock which opens when the chemical acetylcholine (or nicotine) — the key — binds to it, allowing electrical signals or ions to pass through. Investors care because drugs that activate or block these receptors can change brain function, addiction, or muscle control; successful therapies can create large markets, while safety issues or regulatory hurdles around these receptors can affect a drug’s approval and commercial prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What abstinence measures did Achieve Life Sciences assess in the ORCA-OL trial?

ORCA-OL assessed abstinence during 52 weeks of cytisinicline treatment, including biochemically verified four-week sustained abstinence and seven-day point prevalence abstinence. The announcement did not provide results for either measure.