Cytisinicline

Experienced medical executive advances to permanent role following successful leadership as Interim CMOSEATTLE and VANCOUVER, British Columbia, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced that it has confirmed the promotion of Mark Rubinstein, M.D., from Interim Chief Medical Officer to Chief Medical Officer (CMO). Since Dr. Rubinstein began his tenure as Interim CMO in September 2025, the company has achieved significant clinical and regulatory milestones, and he co-authored the recent paper in Thorax of data demonstrating cytisinicline’s potential efficacy and tolerability for smoking cessation in individuals with COPD. "Dr. Rubinstein has been an excellent addition to our leadership team during this pivotal period," said Rick Stewart, President and Chief Executive Officer of Achieve Life Sciences. "His reputation and expertise in nicotine cessation strengthens our medical leadership as we advance toward regulatory review. We are pleased to confirm his appointment to the permanent CMO role, and we're confident the team will continue to drive our progress forward." Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, with a strong focus on nicotine cessation and preventive medicine. Prior to joining Achieve as Head of Medical Affairs in October 2024, he served as Head of Medical Affairs at Blip, where he led medical strategy to support smoking and vaping cessation. Dr. Rubinstein is Professor Emeritus of Pediatrics at the University of California, San Francisco (UCSF), where he served on the faculty for nearly 20 years and conducted NIH-funded research advancing understanding of adolescent nicotine addiction and smoking cessation interventions. He earned his M.D. from Yale School of Medicine, completed his Internal Medicine residency at Yale–New Haven Hospital, and is board-certified in Internal Medicine and Adolescent Medicine. "I am honored to step into the permanent Chief Medical Officer role at this transformative time for Achieve and for patients struggling with nicotine dependence," said Dr. Mark Rubinstein, Chief Medical Officer of Achieve Life Sciences. "The robust safety profile demonstrated by our long-term trial data underscores the potential of cytisinicline to address an important unmet medical need, provide patients with new tools to successfully win their battle with addiction, and reduce the impact of comorbidities associated with nicotine dependence. I look forward to continuing to support our clinical and medical affairs teams as we move forward with the FDA review process." About Achieve Life Sciences, Inc. Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About CytisiniclineThere are approximately 29 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are approximately 17 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. Achieve ContactNicole JonesVP, Strategic Communications and Stakeholder Relationsir@achievelifesciences.com425-686-1510 References1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.4Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025. DOI: https://dx-doi-org.libproxy1.nus.edu.sg/ 10.15620/cdc/174583.5Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.

iStock, photosaint A new analysis from Jefferies shows that drugs receiving breakthrough designations sail through the regulatory process more quickly, on top of frequently winning approval. The vast majority of drugs granted breakthrough designation by the FDA—more than 94%—go on to earn priority reviews from the agency, according to a new report from Jefferies analysts. That report follows a previous analysis from the firm, published in October, that showed 72% of drugs given breakthrough designation (BTD) between 2013 and 2022 went on to win approval, buffing the agency’s ability to identify strong drug candidates early on in the development pipeline. “We have maintained a (+) outlook on the state of the FDA, despite ongoing leadership changes,” the analysts wrote Thursday morning, pointing to the resignation of Center for Drug Evaluation and Research Director (CDER) George Tidmarsh and Richard Pazdur ’s subsequent appointment, as well as to Vinay Prasad, who stepped into his role as director of the Center for Biologics Evaluation and Research in May, left in July and returned in August. Rare diseases Nearly Three Quarters of FDA Breakthrough Designated Drugs Win Approval: Report New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved. October 9, 2025 · 3 min read · Dan Samorodnitsky Taking the two reports together, more than two thirds of drugs that win breakthrough designation also get priority review and then go on to win approval. Between 2013 and 2022, in fact, few if any BTD-designated drugs went through the normal review period. In two years, 2014 and 2022, every single drug to secure breakthrough designation—a total of 48—went on to accelerated review. The success of breakthrough designations, as well as the continued work of FDA advisory committees and the recent decision to release troves of complete response letters, led Jefferies to conclude that the regulatory environment at the FDA remains “largely intact.” Priority reviews shorten a drug’s review time from a standard 10 months to six. A host of sponsors currently hold breakthrough designations that could lead to priority reviews, Jefferies said, including Axsome Therapeutics and its oral drug Auvelity for Azheimer’s disease–related agitation and Savara’s Molbreevi, an inhaled drug for autoimmune pulmonary alveolar proteinosis (aPAP), a rare autoimmune disorder affecting the lungs. Interestingly, a number of drugs holding breakthrough designation were also recently awarded the Commissioner’s National Priority Review Voucher: Achieve Life Sciences’ cytisinicline for nicotine dependance, Revolution Medicines’ daraxonrasib for RAS-addicted cancers, Boehringer Ingelheim’s Hernexeos for non-small cell lung cancer and GSK’s Jemperli for endometrial cancer.