Achieve Life Sciences Confirms Promotion of Dr. Mark Rubinstein to Chief Medical Officer
Rhea-AI Summary
Achieve Life Sciences (Nasdaq: ACHV) confirmed the promotion of Dr. Mark Rubinstein from Interim Chief Medical Officer to permanent Chief Medical Officer, effective Jan. 12, 2026.
Dr. Rubinstein served as Interim CMO since September 2025 and joined Achieve as Head of Medical Affairs in October 2024. The company said clinical and regulatory milestones were achieved during his interim tenure; he co‑authored a paper in Thorax reporting data on cytisinicline’s potential efficacy and tolerability for smoking cessation in people with COPD. Management highlighted his experience as the company advances toward FDA review for cytisinicline.
Positive
- Confirmed appointment of Dr. Mark Rubinstein as CMO effective Jan 12, 2026
- Dr. Rubinstein served as Interim CMO since Sept 2025 during reported clinical and regulatory milestones
- Co‑authorship of a Thorax paper reporting cytisinicline potential efficacy and tolerability in COPD patients
Negative
- None.
News Market Reaction
On the day this news was published, ACHV gained 1.80%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ACHV gained 1.65% while peers were mixed: CHRS up 9.74%, ELDN up 1.17%, ACOG, MIST, and NVCT down between 0.31% and 6.21%, indicating a stock-specific move rather than a unified sector trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 17 | Conference meetings | Positive | +2.6% | Announced investor meetings during J.P. Morgan Healthcare Conference with program overview. |
| Dec 08 | Equity incentives | Neutral | -0.2% | Granted inducement stock options to new hires under equity plan. |
| Nov 06 | Earnings and NDA | Positive | -3.9% | Reported Q3 2025 results, NDA acceptance with PDUFA date, and long-term trial data. |
| Nov 03 | Clinical milestone | Positive | -0.2% | Reported key milestones and long-term safety update supporting cytisinicline NDA. |
| Oct 29 | Earnings scheduling | Neutral | +3.6% | Announced date and access details for Q3 2025 earnings call and webcast. |
Recent news shows mixed reactions: positive regulatory and clinical milestones have sometimes seen negative price responses, while neutral scheduling or corporate updates have drawn modest gains or limited moves.
Over the last few months, ACHV has focused on advancing cytisinicline toward FDA review and engaging investors. On Nov 3, 2025 and Nov 6, 2025, the company reported key NDA milestones, long-term safety data, and Q3 results, including an accepted NDA and a June 20, 2026 PDUFA date, but shares fell after those updates. In contrast, conference participation and corporate scheduling news on Oct 29 and Dec 17, 2025 saw modest positive reactions. Today’s CMO promotion fits into a pattern of building out leadership and medical capabilities as ACHV approaches regulatory review.
Market Pulse Summary
This announcement confirms an experienced physician as permanent CMO during a critical phase for cytisinicline, underscoring continuity in clinical and regulatory leadership. It follows recent milestones including NDA acceptance and long-term safety data supporting smoking cessation, including COPD populations. Investors may track how this appointment supports ongoing FDA interactions, publication strategy, and broader commercialization planning as the company advances toward its previously disclosed June 20, 2026 PDUFA date.
Key Terms
copd medical
nicotine dependence medical
fda regulatory
AI-generated analysis. Not financial advice.
Experienced medical executive advances to permanent role following successful leadership as Interim CMO
SEATTLE 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 Cytisinicline
There 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
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 Statements
This 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 Contact
Nicole Jones
VP, Strategic Communications and Stakeholder Relations
ir@achievelifesciences.com
425-686-1510
References
1VanFrank 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/ 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.
FAQ
What did Achieve Life Sciences announce about Dr. Mark Rubinstein on Jan 12, 2026 (ACHV)?
How long has Dr. Mark Rubinstein served as Interim CMO at Achieve (ACHV)?
What clinical evidence did Dr. Rubinstein co‑author related to cytisinicline and smoking cessation?
How does Dr. Rubinstein’s background support his CMO role at Achieve (ACHV)?
What did Achieve say about regulatory progress for cytisinicline after the CMO appointment?
