Achieve Life Sciences Reaches Key Milestones Submits 120-Day FDA Safety Update, Completes Long-Term ORCA-OL Study For Cytisinicline

Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence, announced key milestones in its ongoing regulatory review with the U.S. FDA. The company has submitted its 120-day safety update for the New Drug Application (NDA) of cytisinicline, containing comprehensive long-term safety data from the ORCA-OL trial. The dataset includes information from 411 participants with at least six months of exposure and 214 participants who received one year of cumulative treatment as of June 2025.

The ORCA-OL long-term safety trial has officially concluded, with the final participant completing treatment in October 2025. A total of 334 participants completed one full year of cytisinicline therapy, surpassing FDA’s request for one-year data from 100 participants and six-month data from 300 participants. This significant level of engagement supports the strength of Achieve’s safety data and patient compliance profile.

The Data Safety Monitoring Committee (DSMC) completed its fourth and final scheduled safety review, reporting no safety concerns and noting that most adverse events were mild. Achieve believes these positive safety outcomes, combined with the robust participation rates, position cytisinicline to become the first new FDA-approved smoking cessation therapy in nearly 20 years. The company remains optimistic that these results reinforce cytisinicline’s potential as a well-tolerated, effective treatment option for nicotine dependence.