Achieve Life Sciences Promotes Mark Rubinstein, M.D., To Chief Medical Officer As Company Advances Cytisinicline Toward FDA Review

Achieve Life Sciences, Inc., a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for the treatment of nicotine dependence and smoking cessation, announced the promotion of Mark Rubinstein, M.D., from Interim Chief Medical Officer to Chief Medical Officer. Dr. Rubinstein has been serving as Interim CMO since September 2025, during which time the company has reached important clinical and regulatory milestones. He also co-authored a recently published paper in Thorax presenting data on the potential efficacy and tolerability of cytisinicline for smoking cessation in individuals with COPD.

Rick Stewart, President and Chief Executive Officer of Achieve Life Sciences, noted that Dr. Rubinstein has been an invaluable member of the leadership team during this crucial phase for the company. He emphasized that Dr. Rubinstein’s strong reputation and deep expertise in nicotine cessation significantly strengthen the company’s medical leadership as it moves toward regulatory review. Stewart added that confirming him as the permanent CMO reflects the company’s confidence in his ability to continue guiding progress.

Dr. Rubinstein has more than twenty years of experience in clinical medicine, scientific research, and medical affairs leadership, with a particular emphasis on nicotine cessation and preventive medicine. Before joining Achieve as Head of Medical Affairs in October 2024, he served as Head of Medical Affairs at Blip, where he oversaw medical strategy supporting smoking and vaping cessation initiatives.

He spent nearly two decades on the faculty at the University of California, San Francisco (UCSF), where he is now Professor Emeritus of Pediatrics. During his academic career, he conducted NIH-funded research that advanced understanding of adolescent nicotine addiction and smoking cessation interventions. Dr. Rubinstein earned his medical degree from Yale School of Medicine, completed his residency in Internal Medicine at Yale–New Haven Hospital, and is board-certified in Internal Medicine and Adolescent Medicine.

Reflecting on his new role, Dr. Rubinstein said he is honored to take on the position of Chief Medical Officer at a transformative moment for the company and for patients dealing with nicotine dependence. He emphasized that the strong safety profile demonstrated in long-term cytisinicline trial data highlights its potential to address a significant unmet medical need, offer patients new tools to overcome addiction, and reduce the health burdens associated with nicotine use. He added that he looks forward to continuing to support Achieve’s clinical and medical affairs teams as the company advances through the FDA review process.