Achieve Life Sciences Unveils 52 Week Safety Data Of Cytisinicline Ahead Of FDA Decision

(RTTNews) - Achieve Life Sciences, Inc. (ACHV), a late-stage specialty pharmaceutical company, announced the presentation of long-term safety data from the ORCA-OL study evaluating its lead investigational candidate, Cytisinicline, for treating nicotine dependence at the American Thoracic Society (ATS) 2026 Annual Meeting According to the firm, the 52-week exposure findings support the long-term tolerability of Cytisinicline in adults with nicotine dependence. Notably, the US Food and Drug Administration (FDA) assigned a June 20, 2026, PDUFA date for the company's Cytisinicline New Drug Application(NDA). Company Profile Achieve Life Sciences develops its lead investigational asset, Cytisinicline, a naturally occurring alkaloid that interacts with nicotine receptors in the brain, reducing the severity of nicotine withdrawal symptoms associated with nicotine dependence. Trial Details The ORCA-OL trial, an open-label, long-term exposure-safety study, enrolled 475 adults who smoke cigarettes (84.6%), use e-cigarettes (12.8%), or both (2.5%). Participants received cytisinicline 3 mg three times daily for up to 52 weeks of continuous exposure, with a median cumulative duration of 361 days. Key Safety Findings -Nausea, a common barrier to treatment adherence with smoking cessation therapies, was reported in 2.5% of participants over 52 weeks of continuous exposure. -Meanwhile, Overall 66.3% of participants experienced one or more treatment-emergent adverse events, but the firm noted that the majority of these were considered unrelated or unlikely to be related to Cytisinicline by the investigator. -94.8% of these adverse events were mild or moderate, with serious adverse events reported in only 6.5% of participants and 5.7% discontinued due to treatment-related adverse events according to the firm. -The most commonly reported adverse events were abnormal dreams (8.4%), insomnia (8.4%), and upper respiratory tract infection (6.7%). -No new safety signals were identified by the independent Data Safety Monitoring Committee. In addition, the firm noted that the final clinical dataset package supports Achieve's New Drug Application (NDA). Additional data on Cytisinicline will be presented at ATS on May 20. Conclusion "The ORCA-OL data represent an important milestone in our regulatory pathway," and "we are positioned to advance Cytisinicline toward potential approval", said Andrew D. Goldberg, Chief Executive Officer of Achieve. Approximately 25 million adults in the United States smoke combustible cigarettes, according to the firm's estimate. Tobacco usage is the leading cause of preventable death, responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually. As of March 31, 2026, the company's cash, cash equivalents, and marketable securities totalled $29.3 million, excluding estimated net proceeds of approximately $168.6 million from a private placement. ACHV has traded between $2.00 and $6.15 over the last year. The stock closed Tuesday's trade at $4.45, down 6.71%. For more such news For More Such Biotech Stock News, visit rttnews.com. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.