Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment

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ORCA-OL data complete the clinical evidence package supporting the cytisinicline smoking cessation NDA

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No new safety signals identified by the independent Data Safety Monitoring Committee over 52 weeks of continuous exposure

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Nausea — a common barrier to treatment adherence with smoking cessation therapies — was reported in only 2.5% of participants over 52 weeks of continuous exposure¹

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SEATTLE and VANCOUVER, British Columbia, May 19, 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 of nicotine dependence, today announced the presentation of comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting. Additional cytisinicline data will be presented at ATS on May 20.

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The ORCA-OL trial, an open-label, long-term, exposure safety study, enrolled 475 adults who smoke cigarettes, use e-cigarettes, or both. Participants received cytisinicline 3 mg three times daily for up to 52 weeks of continuous exposure, with a median cumulative duration of 361 days.¹ This final clinical dataset completes the comprehensive evidence package supporting Achieve’s New Drug Application (NDA), demonstrating that cytisinicline maintains a favorable safety profile across extended treatment duration in a diverse population of adults with nicotine dependence.

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ORCA-OL is the first long-term safety study of cytisinicline in adults using combustible cigarettes, e-cigarettes, or both — extending the clinical safety dataset well beyond the 6- and 12-week treatment durations evaluated in the pivotal Phase 3 ORCA-2 and ORCA-3 trials. The 52-week exposure findings support the long-term tolerability of cytisinicline in adults with nicotine dependence.

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“The ORCA-OL dataset provides important long-term safety and tolerability information across a broad population of adults with nicotine dependence, including individuals using combustible cigarettes and e-cigarettes,” said Mark Rubinstein, MD, Chief Medical Officer of Achieve. “Additional data from our clinical program, shared over the coming days, further reinforce cytisinicline’s potential to address a critical treatment gap. We remain focused on navigating the regulatory process and ultimately bringing this new therapy to patients in need.”

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The ORCA-OL trial included smokers (84.6%), e-cigarette users (12.8%), and dual users (2.5%), adding to the growing safety database for multiple types of nicotine dependence. Among the participants, 66.3% experienced one or more treatment-emergent adverse events, the majority of which were considered unrelated or unlikely to be related to cytisinicline by the investigator. Notably, 94.8% of these adverse events were mild or moderate in severity, with serious adverse events reported in only 6.5% of participants. No new safety signals were identified by the independent Data Safety Monitoring Committee. The most commonly reported adverse events were abnormal dreams (8.4%), insomnia (8.4%), and upper respiratory tract infection (6.7%).¹ The incidence of nausea was 2.5%, consistent with the nausea rates observed across the Phase 3 program, and only 5.7% of participants discontinued the trial due to treatment-related adverse events.

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“The ORCA-OL data represent an important milestone in our regulatory pathway,” said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. “With our complete clinical evidence package now in hand, we are positioned to advance cytisinicline toward potential approval and to bring forward a new, much-needed treatment option for patients.”