Cytisinicline - (ORCA-OL)

September 28, 2026: Achieve Life Sciences (NASDAQ: ACHV) announced that new ORCA-OL data on cytisinicline will be presented at CHEST 2026 (October 18-21, Phoenix) for nicotine dependence, covering both cigarette smoking and e-cigarette cessation. The late-breaking presentation, “Efficacy of 52-Week Cytisinicline Treatment for Cigarette Smoking and E-Cigarette Cessation: The Open-Label ORCA-OL Trial,” is scheduled for October 20, 2026, 2:09-2:13 p.m. MST.

ORCA-OL is an open-label study enrolling 475 adults who had previously participated in ORCA-2, ORCA-3, or ORCA-V1 and were actively smoking and/or vaping daily. Participants received cytisinicline 3 mg three times daily for 52 weeks with behavioral support. The analysis assessed abstinence across the 52-week treatment period, including biochemically verified four-week sustained abstinence and seven-day point prevalence abstinence.

Separately, the company said its NDA for cytisinicline for adult smoking cessation is supported by two successfully completed Phase 3 studies and an open-label long-term safety study. For the vaping cessation indication, Achieve has completed a Phase 2 study, held an end-of-Phase 2 FDA meeting, and received Breakthrough Therapy designation; the press release also says FDA awarded a Commissioner’s National Priority Voucher for e-cigarette or vaping cessation.