Achieve Life Sciences' Cytisinicline Shows 31.2% One-Year Abstinence Rate in ORCA-OL Trial; Shares Rise

Achieve Life Sciences (ACHV) reported 52-week results from its ORCA-OL open-label trial showing 31.2% four-week sustained abstinence during the final four weeks of cytisinicline treatment, sending shares up 1.00% to $6.58. The trial enrolled 479 adults, with 475 receiving cytisinicline 3 mg three times daily for up to 52 weeks plus behavioral support. Abstinence reached 32.8% among exclusive smokers and 24.6% among exclusive vapers. Among participants who received placebo in an earlier ORCA trial, 39.4% achieved abstinence during weeks 49-52. Common treatment-related adverse events included abnormal dreams, insomnia and headache. Discontinuation due to treatment-related events was 3.6%, and the independent safety monitoring committee identified no new safety signals. Results were presented at the CHEST 2026 Annual Meeting. Cytisinicline remains investigational for nicotine dependence, including cigarette smoking and e-cigarette cessation.