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
Should l Buy ACHV?
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: 3.950
Low
10.00
Averages
15.33
High
20.00
Current: 3.950
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.
See More
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.
See More
Achieve Life Sciences to Host Investor Meetings at 2026 J.P. Morgan Healthcare Conference
- Meeting Schedule: Achieve Life Sciences will host in-person one-on-one investor meetings from January 12-15, 2026, at the J.P. Morgan Healthcare Conference in San Francisco, where CEO Rick Stewart will provide insights into the company's late-stage cytisinicline program, aiming to enhance investor confidence in future growth.
- NDA Progress: The New Drug Application for cytisinicline submitted in June 2025 has been accepted for review by the FDA, with a PDUFA date set for June 20, 2026, paving the way for commercialization in the tobacco dependence treatment market.
- Market Demand: With approximately 29 million adults in the U.S. smoking, and tobacco being the leading cause of preventable death, the development of cytisinicline not only addresses this significant market need but also has the potential to greatly improve public health outcomes.
- Clinical Research Results: Based on two successful Phase 3 studies and an open-label safety study, cytisinicline shows promise for smoking and vaping cessation, potentially becoming the first FDA-approved treatment specifically for e-cigarette cessation in the market.
See More
Achieve Life Sciences Grants 250,000 Stock Options to New Chief Legal Officer
- Executive Incentive Program: Achieve Life Sciences has granted 250,000 stock options to new Chief Legal Officer Erik Atkisson, aimed at attracting and retaining key talent, thereby enhancing management stability and execution capability.
- Option Grant Details: These options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly, ensuring Atkisson's commitment to the company's long-term growth.
- Employee Incentive Expansion: Additionally, Achieve has granted a total of 45,000 stock options to two other new employees, further strengthening team building and boosting overall employee morale and loyalty.
- Strategic Development Focus: This option grant aligns with Nasdaq regulations, demonstrating the company's strategic emphasis on talent acquisition and business development, particularly during the critical period of its New Drug Application under FDA review.
See More
Citizens Begins Coverage of Achieve Life Sciences (ACHV) with a Positive Market Outlook
Analyst Coverage Initiation: Citizens initiated coverage of Achieve Life Sciences (NasdaqCM:ACHV) with a "Market Outperform" recommendation, projecting a 298.24% upside based on an average one-year price target of $15.81/share.
Institutional Ownership Trends: There are currently 136 funds reporting positions in Achieve Life Sciences, with a 5.56% decrease in the number of owners over the last quarter, while the average portfolio weight dedicated to ACHV increased by 10.81%.
Shareholder Activity: Propel Bio Management significantly reduced its holdings in ACHV by 62.50%, while other firms like SURI and FBDIX increased their allocations by 949.78% and 73.84%, respectively, indicating mixed sentiment among shareholders.
Market Sentiment Indicators: The put/call ratio for ACHV stands at 0.02, suggesting a bullish outlook, despite a 26.54% decrease in total shares owned by institutions over the past three months.
See More
Citizens Begins Coverage of Achieve Life Sciences with Market Outperform Rating and Sets Price Target at $19
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
See More
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.
See More
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.
See More
Achieve Life Sciences to Host Investor Meetings at 2026 J.P. Morgan Healthcare Conference
- Meeting Schedule: Achieve Life Sciences will host in-person one-on-one investor meetings from January 12-15, 2026, at the J.P. Morgan Healthcare Conference in San Francisco, where CEO Rick Stewart will provide insights into the company's late-stage cytisinicline program, aiming to enhance investor confidence in future growth.
- NDA Progress: The New Drug Application for cytisinicline submitted in June 2025 has been accepted for review by the FDA, with a PDUFA date set for June 20, 2026, paving the way for commercialization in the tobacco dependence treatment market.
- Market Demand: With approximately 29 million adults in the U.S. smoking, and tobacco being the leading cause of preventable death, the development of cytisinicline not only addresses this significant market need but also has the potential to greatly improve public health outcomes.
- Clinical Research Results: Based on two successful Phase 3 studies and an open-label safety study, cytisinicline shows promise for smoking and vaping cessation, potentially becoming the first FDA-approved treatment specifically for e-cigarette cessation in the market.
See More
Achieve Life Sciences Grants 250,000 Stock Options to New Chief Legal Officer
- Executive Incentive Program: Achieve Life Sciences has granted 250,000 stock options to new Chief Legal Officer Erik Atkisson, aimed at attracting and retaining key talent, thereby enhancing management stability and execution capability.
- Option Grant Details: These options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly, ensuring Atkisson's commitment to the company's long-term growth.
- Employee Incentive Expansion: Additionally, Achieve has granted a total of 45,000 stock options to two other new employees, further strengthening team building and boosting overall employee morale and loyalty.
- Strategic Development Focus: This option grant aligns with Nasdaq regulations, demonstrating the company's strategic emphasis on talent acquisition and business development, particularly during the critical period of its New Drug Application under FDA review.
See More
Citizens Begins Coverage of Achieve Life Sciences (ACHV) with a Positive Market Outlook
Analyst Coverage Initiation: Citizens initiated coverage of Achieve Life Sciences (NasdaqCM:ACHV) with a "Market Outperform" recommendation, projecting a 298.24% upside based on an average one-year price target of $15.81/share.
Institutional Ownership Trends: There are currently 136 funds reporting positions in Achieve Life Sciences, with a 5.56% decrease in the number of owners over the last quarter, while the average portfolio weight dedicated to ACHV increased by 10.81%.
Shareholder Activity: Propel Bio Management significantly reduced its holdings in ACHV by 62.50%, while other firms like SURI and FBDIX increased their allocations by 949.78% and 73.84%, respectively, indicating mixed sentiment among shareholders.
Market Sentiment Indicators: The put/call ratio for ACHV stands at 0.02, suggesting a bullish outlook, despite a 26.54% decrease in total shares owned by institutions over the past three months.
See More
Citizens Begins Coverage of Achieve Life Sciences with Market Outperform Rating and Sets Price Target at $19
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
See More
