Achieve Life Sciences Submits NDA for Cytisinicline, Expected U.S. Launch in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
0mins
Source: Benzinga
- 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.
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Analyst Views on ACHV
Wall Street analysts forecast ACHV stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ACHV is 15.33 USD with a low forecast of 10.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.360
Low
10.00
Averages
15.33
High
20.00
Current: 4.360
Low
10.00
Averages
15.33
High
20.00
About ACHV
Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company. The Company focuses on addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. It has completed two Phase III studies with cytisinicline for smoking cessation and one Phase II study with cytisinicline in vaping cessation. Cytisinicline is a naturally occurring, plant-based alkaloid. Cytisinicline is structurally similar to nicotine and has a dual-acting mechanism of action, being both a receptor agonist and antagonist. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine dependence and has not been approved by the Food and Drug Administration for any indication in the United States. Cytisinicline acts as a partial agonist/antagonist, binding to alpha-4 beta-2 nicotinic receptors in the brain and is thought to have two potential consequences in treating nicotine dependence.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
Continue Reading