Achieve Life Sciences Presents 52-Week Cytisinicline Results for Smoking and Vaping Cessation at CHEST 2026
The trial evaluated extended treatment and repeat quit attempts in adults still smoking or vaping after a prior ORCA trial.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Achieve Life Sciences (ACHV) presented 52-week cytisinicline results showing 31.2% four-week sustained abstinence in its open-label ORCA-OL smoking and vaping cessation trial. The analysis included 475 treated adults who were still smoking or vaping after a counseling-supported quit attempt in a prior ORCA trial.
Overall abstinence rose from 25.5% at Weeks 9–12 to 30.3% at Weeks 21–24. At Weeks 49–52, rates were 39.4% for prior placebo recipients and 27.8% for prior cytisinicline recipients. Rates were 32.8% among exclusive smokers and 24.6% among exclusive vapers. Of 479 enrolled participants, 69.7% completed the 52-week study. Treatment-related adverse events included abnormal dreams (7.8%), insomnia (6.5%) and headache (3.8%); 3.6% discontinued because of treatment-related adverse events. The independent safety monitoring committee identified no new safety signals. Results were presented at CHEST 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointFour-week sustained abstinence rose from 25.5% at Weeks 9–12 to 30.3% at Weeks 21–24 and 31.2% at Weeks 49–52.
- Minor pointPrior placebo recipients recorded 39.4% abstinence at Weeks 49–52, versus 26.3% at Weeks 9–12.
- Minor pointPrior cytisinicline recipients recorded 27.8% abstinence at Weeks 49–52 during a repeat quit attempt.
- Minor pointExclusive smokers recorded 32.8% abstinence at Weeks 49–52.
- Minor pointExclusive vapers recorded 24.6% abstinence at Weeks 49–52.
- Minor pointIndependent safety monitoring identified no new safety signals.
Negative
- Minor pointOpen-label design evaluated cytisinicline alongside behavioral support rather than a blinded treatment comparison.
- Minor point52-week study completion was 69.7% (334/479 enrolled).
- Minor pointTreatment-related adverse events included abnormal dreams (7.8%), insomnia (6.5%), headache (3.8%) and nausea (1.5%).
- Minor pointTreatment-related adverse events led 3.6% of participants to discontinue.
Details
Market Reaction – ACHV
On Oct 21, the day this news came out, the latest delayed price for ACHV is 1.77% above the previous close. Our momentum scanner has recorded 2 alerts for this stock so far that day. The latest delayed price is $6.63. Relative volume is elevated at 2.1x the average.
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Key Figures
- Analysis population
- 475 participants
- ORCA-OL; received at least one dose
- Four-week sustained abstinence
- 31.2%
- Total study population, Weeks 49–52
- Four-week sustained abstinence
- 39.4%
- Prior-trial placebo participants, Weeks 49–52
- Four-week sustained abstinence
- 27.8%
- Prior-trial cytisinicline participants, Weeks 49–52
- Quit rate
- 32.8%
- Participants who exclusively smoked, end of year
- Quit rate
- 24.6%
- Participants who exclusively vaped, end of year
- Study completion
- 69.7% (334/479 enrolled)
- 52-week study
- Treatment-related adverse event discontinuation
- 3.6%
- ORCA-OL participants
Key Terms
open-label technical
four-week sustained abstinence medical
point prevalence abstinence medical
data safety monitoring committee medical
new drug application regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Nearly one in three adults who were still smoking or vaping after a prior ORCA trial had quit at the end of a year of cytisinicline treatment, with quit rates rising through the year
Among the participants new to cytisinicline (prior attempt on placebo),
Participants were in their mid-fifties on average, ranging up to age 79, and many had a history of chronic conditions; the typical participant who smoked had made five quit attempts before ORCA-OL, and every participant chose to try again
SEATTLE and VANCOUVER, British Columbia, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (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 positive 52-week efficacy results from its long-term, open-label ORCA-OL clinical trial evaluating cytisinicline for cigarette smoking and e-cigarette cessation. The findings were presented at the CHEST 2026 Annual Meeting in Phoenix, Arizona.
The ORCA-OL trial enrolled 479 adults, of whom 475 received at least one dose of cytisinicline 3 mg three times daily for up to 52 weeks and form the analysis population. Of these,
All of these are repeat-attempt results: the participants who smoked had made a median of five quit attempts before ORCA-OL, including their prior ORCA trial. Among participants who had received placebo in their prior trial and were still smoking or vaping,
“Most people need more than one attempt to quit, yet treatment beyond 12 weeks and retreatment had not previously been studied with cytisinicline,” said Mark Rubinstein, MD, Chief Medical Officer, Achieve. “These results provide the first data on extended treatment and retreatment with cytisinicline, and suggest that longer treatment of up to 52 weeks may help some people who smoke or vape sustain abstinence.”
“This is the first year-long treatment trial we know of in people who were still smoking or vaping after a medically supported quit attempt, and the people in it look like the patients clinicians see every day: older, on other medications, and living with chronic conditions, many having also tried other treatments and still smoking,” said Andrew D. Goldberg, MD, Chief Executive Officer, Achieve. “Every one of them chose to try again, and nearly a third were not smoking or vaping at the end of a year.”
The median duration of cytisinicline exposure was 361 days, with
ORCA-OL was an open-label study designed to evaluate the long-term safety, tolerability, and efficacy of cytisinicline in adults who smoke cigarettes, use nicotine-containing e-cigarettes, or use both products. Participants received cytisinicline 3 mg three times daily alongside behavioral support for up to 52 weeks. Efficacy assessments included four-week sustained abstinence and seven-day point prevalence abstinence, providing insights into cessation outcomes during extended treatment.
Achieve has completed two Phase 3 clinical trials, ORCA-2 and ORCA-3, evaluating cytisinicline for smoking cessation, as well as the Phase 2 ORCA-V1 trial evaluating cytisinicline for vaping cessation. The ORCA-OL findings provide additional long-term clinical evidence supporting the potential role of cytisinicline in treating nicotine dependence.
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 an investigational compound that binds to nicotinic receptors. It is being developed as an aid to smoking cessation treatment in adults and as an aid to nicotine e-cigarette cessation.
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 for 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 ORCA-OL results and their interpretation, the potential of cytisinicline for extended treatment, retreatment, and smoking and vaping cessation, the timing and outcome of Achieve’s planned NDA resubmission for cytisinicline, the timing of any FDA decision, the potential benefits of cytisinicline, the potential market for cytisinicline, 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. ORCA-OL was an open-label, uncontrolled study, and its results, including results in subgroups of participants, may not be predictive of results in controlled clinical trials or in clinical practice. 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.
Contact
Nicole Jones
VP, Strategic Communications and Stakeholder Relations
ir@achievelifesciences.com
media@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 did Achieve Life Sciences report from the 52-week ORCA-OL cytisinicline trial?
Four-week sustained abstinence reached 31.2% at Weeks 49–52, compared with 25.5% at Weeks 9–12 and 30.3% at Weeks 21–24. All participants were still smoking or vaping after a counseling-supported quit attempt in a prior ORCA trial.
What safety results did Achieve report for long-term cytisinicline treatment?
The independent safety monitoring committee identified no new safety signals. Treatment-related adverse events included abnormal dreams (7.8%), insomnia (6.5%), headache (3.8%) and nausea (1.5%). Treatment-related adverse events led 3.6% of participants to discontinue.
How was cytisinicline given in Achieve's ORCA-OL trial?
Participants received cytisinicline 3 mg three times daily alongside behavioral support for up to 52 weeks. Median treatment exposure was 361 days.
What was the treatment history of participants in Achieve's ORCA-OL trial?
Participants who smoked had made a median of five quit attempts before ORCA-OL, including their prior ORCA trial. Across the study population, 71% had received cytisinicline in the prior trial. More than a third of those who smoked had also tried varenicline, bupropion, or both and were still smoking.