Achieve Life Sciences Appoints Mark Rubinstein as Chief Medical Officer
Achieve Life Sciences announced that it has confirmed the promotion of Mark Rubinstein, M.D., from Interim Chief Medical Officer to Chief Medical Officer. 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, the company said in a statement. "Dr. Rubinstein has been an excellent addition to our leadership team during this pivotal period," said Rick Stewart, President and CEO 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."
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Achieve Life Sciences Appoints Mark Rubinstein as Chief Medical Officer
- Leadership Change: Achieve Life Sciences has confirmed the promotion of Mark Rubinstein from Interim Chief Medical Officer to Chief Medical Officer, having played a crucial role in achieving significant clinical and regulatory milestones since September 2025.
- Clinical Achievements: Under Rubinstein's leadership, the company co-authored a paper published in Thorax, demonstrating the potential efficacy and tolerability of cytisinicline for smoking cessation in COPD patients, further advancing the product's clinical development.
- Company Confidence: Achieve Life Sciences' CEO Rick Stewart stated that Rubinstein's expertise strengthens the company's medical leadership, ensuring continued progress toward regulatory review.
- Strategic Implications: This appointment not only solidifies the company's leadership position in nicotine cessation but also lays the groundwork for future regulatory approvals and market entry, reflecting the company's commitment to advancing its product pipeline.

Achieve Life Sciences Submits NDA for Cytisinicline, Expected U.S. Launch in 2026
- NDA Submission: Achieve Life Sciences submitted a New Drug Application for cytisinicline to the FDA in June 2025, with a U.S. launch expected in 2026, which could mark the first FDA-approved smoking cessation therapy in nearly 20 years, significantly enhancing the company's competitive position in the tobacco alternatives market.
- Market Potential: According to the Hunterbrook report, cytisinicline is considered the best therapy for quitting smoking, and with most U.S. health plans required to cover FDA-approved cessation therapies, it is expected to attract a large user base, driving revenue growth for the company.
- Safety Advantage: Cytisinicline demonstrates a more favorable safety and efficacy profile compared to former market leaders like Pfizer's Chantix, showing no risk of suicidal ideation, which will enhance confidence among healthcare providers and patients, promoting market acceptance.
- Strong Expert Support: Numerous public health experts and researchers unanimously agree that cytisinicline warrants FDA approval without the need for additional clinical data, and this broad support is likely to expedite its market entry, further solidifying Achieve Life Sciences' leadership in smoking cessation treatments.








