{"success":true,"data":{"pressRelease":{"id":"154110","rtpr_id":"nGNX3HMwMk-20260928","ticker":"ACHV","exchange":"NASDAQ","all_tickers":["ACHV"],"title":"Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026","author":"Globe Newswire","published_at":"2026-09-28T12:30:00.196Z","article_body":"SEATTLE and VANCOUVER, British Columbia, Sept. 28, 2026 (GLOBE NEWSWIRE) --\nAchieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty\npharmaceutical company focused on the global development and commercialization\nof cytisinicline as a treatment for nicotine dependence, today announced that\nnew data evaluating the efficacy of 52 weeks of cytisinicline treatment for\ncigarette smoking and e-cigarette cessation will be presented at CHEST 2026,\nheld October 18-21 in Phoenix, Arizona.\n\nCHEST 2026 Presentation Details\n* Presentation Title: Efficacy of 52-Week Cytisinicline Treatment for\nCigarette Smoking and E-Cigarette Cessation: The Open-Label ORCA-OL Trial\n* Session: Top Late-Breaking Abstracts: New Trial Data from Bench to\nBronchoscope\n* Date/Time: Tuesday, October 20, 2026, 2:09–2:13 p.m. MST\n* Presenter: Mark Rubinstein, MD, Chief Medical Officer, Achieve Life Sciences\n* Authors: Judith J. Prochaska, PhD, MPH, Stanford University; Neal L.\nBenowitz, MD, University of California, San Francisco; Dorothy K. Hatsukami,\nPhD, Masonic Cancer Center, University of Minnesota; Matthew E. Linley-Adams,\nAchieve Life Sciences; Mark L. Rubinstein, MD, Achieve Life Sciences; Nancy A.\nRigotti, MD, Harvard Medical School\nThe presentation will feature results from ORCA-OL, an open-label study that\nenrolled 475 adults who previously participated in the ORCA-2, ORCA-3 or\nORCA-V1 trials and were actively smoking cigarettes and/or vaping daily.\nParticipants received cytisinicline 3 mg three times daily for 52 weeks with\nbehavioral support. The analysis evaluated abstinence throughout the 52-week\ntreatment period, including biochemically verified four-week sustained\nabstinence and seven-day point prevalence abstinence.\n\nFor more information about the conference, visit\nhttps://www.chestnet.org/learning-and-events/events/chest-annual-meeting.\n\nAbout Cytisinicline\nThere are approximately 25 million adults in the United States who smoke\ncombustible cigarettes.¹ Tobacco use is currently the leading cause of\npreventable death, responsible for more than seven million deaths worldwide\nand nearly half a million deaths in the United States annually.²,³\n\nIn addition, there are nearly 18 million adults in the United States who use\ne-cigarettes, also known as vaping.¹ In 2025, approximately 1.4 million\nmiddle and high school students in the United States reported using\ne-cigarettes.⁴ There are no FDA-approved treatments indicated specifically\nas an aid to nicotine e-cigarette cessation. FDA has awarded Achieve the\nCommissioner’s National Priority Voucher for e-cigarette or vaping cessation\nand granted Breakthrough Therapy designation to address this critical need.\n\nCytisinicline is a plant-based alkaloid with a high binding affinity to the\nnicotinic acetylcholine receptor. It is believed to aid in treating nicotine\ndependence for smoking and e-cigarette cessation by interacting with nicotine\nreceptors in the brain, reducing the severity of nicotine craving symptoms,\nand reducing the reward and satisfaction associated with nicotine products.\n\nAbout Achieve Life Sciences, Inc.\nAchieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company\nfocused on the global development and commercialization of cytisinicline as a\ntreatment of nicotine dependence. Achieve’s New Drug Application (NDA) for\ncytisinicline for smoking cessation in adults is supported by two successfully\ncompleted Phase 3 studies and an open-label long-term safety study. Achieve\nhas also completed a Phase 2 study of cytisinicline in nicotine e-cigarette\ncessation, conducted an end-of-Phase 2 meeting with the FDA, and has received\nBreakthrough Therapy designation for the vaping cessation indication.\n\nForward Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe “safe harbor” provisions of the Private Securities Litigation Reform\nAct of 1995. All statements other than statements of historical fact are\nstatements that could be deemed forward-looking statements, including, without\nlimitation, statements regarding the potential benefits of cytisinicline, the\npotential market for cytisinicline, and the Company’s commercialization\nplans and readiness. Achieve may not achieve its plans, projections, or other\nexpectations and may not be able to successfully complete its NDA resubmission\nor obtain regulatory approval for cytisinicline on the anticipated timeline or\nat all. These statements are based on management’s current expectations and\nbeliefs and are subject to risks, uncertainties, and assumptions that could\ncause actual results to differ materially from those described in the\nforward-looking statements, including those detailed in Achieve’s most\nrecent Annual Report on Form 10-K and subsequent Quarterly Reports on Form\n10-Q filed with the Securities and Exchange Commission. Achieve undertakes no\nobligation to update or revise any forward-looking statements, whether as a\nresult of new information, future events, or otherwise, except as required by\napplicable law.\n\nAchieve Contact\nInvestor Relations\nNicole Jones\nir@achievelifesciences.com\n425-686-1510\n\nReferences\n¹Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM Evidence,\ndoi: 10.1056/EVIDpha2500339.\n²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2025.\nGeneva: World Health Organization; 2025.\n³U.S. Department of Health and Human Services. The Health Consequences of\nSmoking, 50 Years of Progress. A Report of the Surgeon General. Centers for\nDisease Control and Prevention, National Center for Chronic Disease Prevention\nand Health Promotion, Office on Smoking and Health; 2014.\n⁴Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use\nAmong Middle and High School Students in the United States: National Youth\nTobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116,\ndoi.org/10.1093/ntr/ntag116.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1026e030-275c-4391-8f9a-65c5c1ec7b88)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3HMwMk-20260928","title":"Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026","author":"Globe Newswire","ticker":"ACHV","created":"2026-09-28T12:30:00.196Z","tickers":["ACHV"],"exchange":"NASDAQ","article_body":"SEATTLE and VANCOUVER, British Columbia, Sept. 28, 2026 (GLOBE NEWSWIRE) --\nAchieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty\npharmaceutical company focused on the global development and commercialization\nof cytisinicline as a treatment for nicotine dependence, today announced that\nnew data evaluating the efficacy of 52 weeks of cytisinicline treatment for\ncigarette smoking and e-cigarette cessation will be presented at CHEST 2026,\nheld October 18-21 in Phoenix, Arizona.\n\nCHEST 2026 Presentation Details\n* Presentation Title: Efficacy of 52-Week Cytisinicline Treatment for\nCigarette Smoking and E-Cigarette Cessation: The Open-Label ORCA-OL Trial\n* Session: Top Late-Breaking Abstracts: New Trial Data from Bench to\nBronchoscope\n* Date/Time: Tuesday, October 20, 2026, 2:09–2:13 p.m. MST\n* Presenter: Mark Rubinstein, MD, Chief Medical Officer, Achieve Life Sciences\n* Authors: Judith J. Prochaska, PhD, MPH, Stanford University; Neal L.\nBenowitz, MD, University of California, San Francisco; Dorothy K. Hatsukami,\nPhD, Masonic Cancer Center, University of Minnesota; Matthew E. Linley-Adams,\nAchieve Life Sciences; Mark L. Rubinstein, MD, Achieve Life Sciences; Nancy A.\nRigotti, MD, Harvard Medical School\nThe presentation will feature results from ORCA-OL, an open-label study that\nenrolled 475 adults who previously participated in the ORCA-2, ORCA-3 or\nORCA-V1 trials and were actively smoking cigarettes and/or vaping daily.\nParticipants received cytisinicline 3 mg three times daily for 52 weeks with\nbehavioral support. The analysis evaluated abstinence throughout the 52-week\ntreatment period, including biochemically verified four-week sustained\nabstinence and seven-day point prevalence abstinence.\n\nFor more information about the conference, visit\nhttps://www.chestnet.org/learning-and-events/events/chest-annual-meeting.\n\nAbout Cytisinicline\nThere are approximately 25 million adults in the United States who smoke\ncombustible cigarettes.¹ Tobacco use is currently the leading cause of\npreventable death, responsible for more than seven million deaths worldwide\nand nearly half a million deaths in the United States annually.²,³\n\nIn addition, there are nearly 18 million adults in the United States who use\ne-cigarettes, also known as vaping.¹ In 2025, approximately 1.4 million\nmiddle and high school students in the United States reported using\ne-cigarettes.⁴ There are no FDA-approved treatments indicated specifically\nas an aid to nicotine e-cigarette cessation. FDA has awarded Achieve the\nCommissioner’s National Priority Voucher for e-cigarette or vaping cessation\nand granted Breakthrough Therapy designation to address this critical need.\n\nCytisinicline is a plant-based alkaloid with a high binding affinity to the\nnicotinic acetylcholine receptor. It is believed to aid in treating nicotine\ndependence for smoking and e-cigarette cessation by interacting with nicotine\nreceptors in the brain, reducing the severity of nicotine craving symptoms,\nand reducing the reward and satisfaction associated with nicotine products.\n\nAbout Achieve Life Sciences, Inc.\nAchieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company\nfocused on the global development and commercialization of cytisinicline as a\ntreatment of nicotine dependence. Achieve’s New Drug Application (NDA) for\ncytisinicline for smoking cessation in adults is supported by two successfully\ncompleted Phase 3 studies and an open-label long-term safety study. Achieve\nhas also completed a Phase 2 study of cytisinicline in nicotine e-cigarette\ncessation, conducted an end-of-Phase 2 meeting with the FDA, and has received\nBreakthrough Therapy designation for the vaping cessation indication.\n\nForward Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe “safe harbor” provisions of the Private Securities Litigation Reform\nAct of 1995. All statements other than statements of historical fact are\nstatements that could be deemed forward-looking statements, including, without\nlimitation, statements regarding the potential benefits of cytisinicline, the\npotential market for cytisinicline, and the Company’s commercialization\nplans and readiness. Achieve may not achieve its plans, projections, or other\nexpectations and may not be able to successfully complete its NDA resubmission\nor obtain regulatory approval for cytisinicline on the anticipated timeline or\nat all. These statements are based on management’s current expectations and\nbeliefs and are subject to risks, uncertainties, and assumptions that could\ncause actual results to differ materially from those described in the\nforward-looking statements, including those detailed in Achieve’s most\nrecent Annual Report on Form 10-K and subsequent Quarterly Reports on Form\n10-Q filed with the Securities and Exchange Commission. Achieve undertakes no\nobligation to update or revise any forward-looking statements, whether as a\nresult of new information, future events, or otherwise, except as required by\napplicable law.\n\nAchieve Contact\nInvestor Relations\nNicole Jones\nir@achievelifesciences.com\n425-686-1510\n\nReferences\n¹Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM Evidence,\ndoi: 10.1056/EVIDpha2500339.\n²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2025.\nGeneva: World Health Organization; 2025.\n³U.S. Department of Health and Human Services. The Health Consequences of\nSmoking, 50 Years of Progress. A Report of the Surgeon General. Centers for\nDisease Control and Prevention, National Center for Chronic Disease Prevention\nand Health Promotion, Office on Smoking and Health; 2014.\n⁴Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use\nAmong Middle and High School Students in the United States: National Youth\nTobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116,\ndoi.org/10.1093/ntr/ntag116.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1026e030-275c-4391-8f9a-65c5c1ec7b88)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-28T12:30:00.238622476Z","server_sent_at_ms":1790598600238},"received_at":"2026-09-28T12:30:00.290Z","source_url":null},"analysis":{"id":"142891","press_release_id":"154110","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["forward-looking statements note the company may not successfully complete its NDA resubmission or obtain approval"],"eventType":"clinical_trial","narrative":"Achieve Life Sciences will present 52-week cytisinicline efficacy data for cigarette smoking and e-cigarette cessation at CHEST 2026 on October 20 in Phoenix.\n\nThe data come from the open-label ORCA-OL trial, which enrolled 475 adults from the prior ORCA-2, ORCA-3 and ORCA-V1 studies, treated with 3 mg three times daily for 52 weeks.\n\nThe company notes its smoking-cessation NDA is under review and that FDA granted Breakthrough Therapy designation and a National Priority Voucher for the vaping-cessation indication.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"Conference presentation of 52-week cytisinicline data reinforces long-term efficacy narrative ahead of NDA resubmission."},"keyFigures":{"drugName":"cytisinicline","phaseOfTrial":"open-label ORCA-OL (Phase 3 follow-on)","customDimensions":{"trial_enrollment":475,"treatment_duration_weeks":52}},"namedEntities":{"people":[{"name":"Mark Rubinstein","role":"Chief Medical Officer / presenter"},{"name":"Judith J. Prochaska","role":"author, Stanford University"},{"name":"Neal L. Benowitz","role":"author, UCSF"},{"name":"Dorothy K. Hatsukami","role":"author, Masonic Cancer Center, University of Minnesota"},{"name":"Matthew E. Linley-Adams","role":"author, Achieve Life Sciences"},{"name":"Nancy A. Rigotti","role":"author, Harvard Medical School"},{"name":"Nicole Jones","role":"Investor Relations contact"}],"products":["cytisinicline","ORCA-OL"],"companies":[{"name":"Achieve Life Sciences, Inc.","ticker":"ACHV"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"A conference presentation announcement of 52-week open-label efficacy data (ORCA-OL); no new results disclosed in the release and no regulatory decision. Mildly supportive of the data package but largely promotional."},"tickerRelevance":{"others":[],"primary":"ACHV"},"globalImportance":22,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"conference-data-presentation","newDataDisclosed":false,"regulatoryCatalystPending":true}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"neutral","material_impact_score":2,"narrative":"Achieve Life Sciences will present 52-week cytisinicline efficacy data for cigarette smoking and e-cigarette cessation at CHEST 2026 on October 20 in Phoenix.\n\nThe data come from the open-label ORCA-OL trial, which enrolled 475 adults from the prior ORCA-2, ORCA-3 and ORCA-V1 studies, treated with 3 mg three times daily for 52 weeks.\n\nThe company notes its smoking-cessation NDA is under review and that FDA granted Breakthrough Therapy designation and a National Priority Voucher for the vaping-cessation indication.","key_figures":{"drugName":"cytisinicline","phaseOfTrial":"open-label ORCA-OL (Phase 3 follow-on)","customDimensions":{"trial_enrollment":475,"treatment_duration_weeks":52}},"named_entities":{"people":[{"name":"Mark Rubinstein","role":"Chief Medical Officer / presenter"},{"name":"Judith J. Prochaska","role":"author, Stanford University"},{"name":"Neal L. Benowitz","role":"author, UCSF"},{"name":"Dorothy K. Hatsukami","role":"author, Masonic Cancer Center, University of Minnesota"},{"name":"Matthew E. Linley-Adams","role":"author, Achieve Life Sciences"},{"name":"Nancy A. Rigotti","role":"author, Harvard Medical School"},{"name":"Nicole Jones","role":"Investor Relations contact"}],"products":["cytisinicline","ORCA-OL"],"companies":[{"name":"Achieve Life Sciences, Inc.","ticker":"ACHV"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-28T12:30:06.189Z","global_importance":22,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap","eventGravity":"conference-data-presentation","newDataDisclosed":false,"regulatoryCatalystPending":true}},"durationMs":5782,"modelName":"glm-5.3-flashx"}}