Achieve Life Sciences Presents Long-Term Safety Data for Cytisinicline
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 19 2026
0mins
Source: Newsfilter
- Clinical Data Completeness: Achieve Life Sciences presented comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society 2026 Annual Meeting, reinforcing the foundation for its New Drug Application (NDA) and future market access.
- Safety Analysis Results: Among 475 participants, only 2.5% reported nausea during 52 weeks of continuous exposure, indicating good tolerability of the treatment, with 94.8% of adverse events classified as mild or moderate, demonstrating the drug's safety across a diverse population.
- Market Demand Opportunity: With approximately 25 million adults smoking in the U.S. and no FDA-approved treatments for e-cigarette cessation, the development of Cytisinicline addresses this critical market gap, expected to meet the rising demand for smoking cessation solutions.
- Regulatory Progress: Achieve has submitted its NDA to the FDA, with a review date set for June 20, 2026; as clinical evidence solidifies, the company is poised to potentially launch this much-needed treatment option, further driving business growth.
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Analyst Views on ACHV
Wall Street analysts forecast ACHV stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 4.560
Low
12.00
Averages
15.50
High
19.00
Current: 4.560
Low
12.00
Averages
15.50
High
19.00
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 Presents Long-Term Safety Data for Cytisinicline
- Long-Term Safety Study: Achieve Life Sciences presented long-term safety data for Cytisinicline at the American Thoracic Society 2026 Annual Meeting, with 52-week findings indicating good tolerability in adults with nicotine dependence, potentially paving the way for future regulatory approvals.
- FDA Review Progress: The FDA has set a PDUFA date of June 20, 2026, for Cytisinicline's New Drug Application, marking a significant advancement in the company's efforts to bring the drug to market, which is likely to attract increased investor interest.
- Clinical Trial Participant Data: The ORCA-OL trial enrolled 475 smokers, with 84.6% being cigarette smokers and 12.8% e-cigarette users, demonstrating Cytisinicline's broad applicability across different smoking populations, which may enhance market acceptance.
- Adverse Event Monitoring: While 66.3% of participants reported treatment-related adverse events, most were deemed unrelated to Cytisinicline, and 94.8% of these events were mild or moderate, indicating the drug's safety and potentially boosting physician confidence in prescribing it.
See More
Achieve Life Sciences Presents Long-Term Safety Data for Cytisinicline
- Clinical Data Completeness: Achieve Life Sciences presented comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society 2026 Annual Meeting, reinforcing the foundation for its New Drug Application (NDA) and future market access.
- Safety Analysis Results: Among 475 participants, only 2.5% reported nausea during 52 weeks of continuous exposure, indicating good tolerability of the treatment, with 94.8% of adverse events classified as mild or moderate, demonstrating the drug's safety across a diverse population.
- Market Demand Opportunity: With approximately 25 million adults smoking in the U.S. and no FDA-approved treatments for e-cigarette cessation, the development of Cytisinicline addresses this critical market gap, expected to meet the rising demand for smoking cessation solutions.
- Regulatory Progress: Achieve has submitted its NDA to the FDA, with a review date set for June 20, 2026; as clinical evidence solidifies, the company is poised to potentially launch this much-needed treatment option, further driving business growth.
See More
Achieve Life Sciences Q1 2026 Earnings Call Insights
- Successful Financing: Achieve Life Sciences secured $180 million in upfront financing and potential milestone-based warrants of up to $174 million, providing robust financial backing for ongoing investments in smoking and vaping cessation drug development, thereby positioning the company for future growth.
- Regulatory Challenges: The company anticipates receiving a complete response letter from the FDA by the June 20 PDUFA date, primarily due to cGMP issues at a third-party manufacturer, which may impact the timeline for NDA resubmission planned for Q4 2026.
- Clinical Data Highlights: Participants receiving cytisinicline achieved a continuous abstinence rate of 32.4% compared to 6% in the placebo group, indicating the drug's potential efficacy in smoking cessation treatment, which could lay the groundwork for future market promotion.
- Commercialization Strategy Shift: The company plans to commercialize independently with its own sales force and aims to initiate the ORCA-V2 vaping Phase III clinical trial this year, a strategic shift that will enhance its market competitiveness and broaden product coverage.
See More
Achieve Life Sciences Appoints Three Senior Executives
- Executive Appointments: Achieve Life Sciences has appointed Christopher Martin to its Board of Directors, Mark Zappia as Senior Vice President of Commercial, and Jim Willis as Vice President of Sales, all of whom bring successful commercial experience from Verona Pharma, which is expected to drive the company towards commercialization.
- Financing Context: These appointments come on the heels of Achieve securing up to $354 million in financing, including $180 million upfront and up to $174 million from milestone-based warrants tied to FDA approval, demonstrating the company's commitment to advancing cytisinicline's commercialization.
- Market Potential: Cytisinicline could become the first new smoking cessation therapy in over two decades and the first ever for vaping cessation, addressing the urgent needs of approximately 25 million smokers and 18 million e-cigarette users in the U.S., indicating significant market potential.
- Leadership Confidence: New CEO Andrew D. Goldberg stated that the addition of these executives is one of the most consequential decisions of his tenure, reflecting Achieve's strategic positioning to tackle public health issues and enhancing confidence in the company's future growth.
See More
Achieve Life Sciences Q1 2026 Earnings Beat Expectations
- Strong Earnings Report: Achieve Life Sciences reported a Q1 GAAP EPS of -$0.19, beating market expectations by $0.11, indicating improvements in financial management that may boost investor confidence.
- Healthy Cash Position: As of March 31, 2026, the company had $29.3 million in cash, cash equivalents, and marketable securities, excluding estimated net proceeds of approximately $168.6 million from private placements, reflecting positive fundraising progress.
- Private Placement Announcement: Achieve Life Sciences announced a private placement of up to $354 million, which is expected to further strengthen the company's capital structure and provide funding for future R&D and market expansion.
- Market Reaction Analysis: Despite a recent sell-off, analysts maintain a 'Buy' rating, anticipating that the upcoming PDUFA and expansion into vaping cessation will present new growth opportunities for the company.
See More
Achieve Life Sciences to Report Q1 2026 Financial Results on May 12
- Earnings Announcement: Achieve Life Sciences will report its Q1 2026 financial results and provide a corporate update on May 12, 2026, at 8:30 AM EDT, which is expected to positively influence investor confidence.
- FDA Review 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 potential market launch.
- Market Demand Context: Approximately 25 million adults in the U.S. smoke, with tobacco use causing over 500,000 deaths annually, highlighting the urgent need for effective smoking cessation treatments, which cytisinicline aims to address.
- Clinical Research Outcomes: Cytisinicline has completed multiple clinical studies for smoking and vaping cessation, with successful Phase 3 results laying a strong foundation for future commercialization, potentially enhancing the company's competitive position in the market.
See More
Achieve Life Sciences Presents Long-Term Safety Data for Cytisinicline
- Long-Term Safety Study: Achieve Life Sciences presented long-term safety data for Cytisinicline at the American Thoracic Society 2026 Annual Meeting, with 52-week findings indicating good tolerability in adults with nicotine dependence, potentially paving the way for future regulatory approvals.
- FDA Review Progress: The FDA has set a PDUFA date of June 20, 2026, for Cytisinicline's New Drug Application, marking a significant advancement in the company's efforts to bring the drug to market, which is likely to attract increased investor interest.
- Clinical Trial Participant Data: The ORCA-OL trial enrolled 475 smokers, with 84.6% being cigarette smokers and 12.8% e-cigarette users, demonstrating Cytisinicline's broad applicability across different smoking populations, which may enhance market acceptance.
- Adverse Event Monitoring: While 66.3% of participants reported treatment-related adverse events, most were deemed unrelated to Cytisinicline, and 94.8% of these events were mild or moderate, indicating the drug's safety and potentially boosting physician confidence in prescribing it.
See More
Achieve Life Sciences Presents Long-Term Safety Data for Cytisinicline
- Clinical Data Completeness: Achieve Life Sciences presented comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society 2026 Annual Meeting, reinforcing the foundation for its New Drug Application (NDA) and future market access.
- Safety Analysis Results: Among 475 participants, only 2.5% reported nausea during 52 weeks of continuous exposure, indicating good tolerability of the treatment, with 94.8% of adverse events classified as mild or moderate, demonstrating the drug's safety across a diverse population.
- Market Demand Opportunity: With approximately 25 million adults smoking in the U.S. and no FDA-approved treatments for e-cigarette cessation, the development of Cytisinicline addresses this critical market gap, expected to meet the rising demand for smoking cessation solutions.
- Regulatory Progress: Achieve has submitted its NDA to the FDA, with a review date set for June 20, 2026; as clinical evidence solidifies, the company is poised to potentially launch this much-needed treatment option, further driving business growth.
See More
Achieve Life Sciences Q1 2026 Earnings Call Insights
- Successful Financing: Achieve Life Sciences secured $180 million in upfront financing and potential milestone-based warrants of up to $174 million, providing robust financial backing for ongoing investments in smoking and vaping cessation drug development, thereby positioning the company for future growth.
- Regulatory Challenges: The company anticipates receiving a complete response letter from the FDA by the June 20 PDUFA date, primarily due to cGMP issues at a third-party manufacturer, which may impact the timeline for NDA resubmission planned for Q4 2026.
- Clinical Data Highlights: Participants receiving cytisinicline achieved a continuous abstinence rate of 32.4% compared to 6% in the placebo group, indicating the drug's potential efficacy in smoking cessation treatment, which could lay the groundwork for future market promotion.
- Commercialization Strategy Shift: The company plans to commercialize independently with its own sales force and aims to initiate the ORCA-V2 vaping Phase III clinical trial this year, a strategic shift that will enhance its market competitiveness and broaden product coverage.
See More
Achieve Life Sciences Appoints Three Senior Executives
- Executive Appointments: Achieve Life Sciences has appointed Christopher Martin to its Board of Directors, Mark Zappia as Senior Vice President of Commercial, and Jim Willis as Vice President of Sales, all of whom bring successful commercial experience from Verona Pharma, which is expected to drive the company towards commercialization.
- Financing Context: These appointments come on the heels of Achieve securing up to $354 million in financing, including $180 million upfront and up to $174 million from milestone-based warrants tied to FDA approval, demonstrating the company's commitment to advancing cytisinicline's commercialization.
- Market Potential: Cytisinicline could become the first new smoking cessation therapy in over two decades and the first ever for vaping cessation, addressing the urgent needs of approximately 25 million smokers and 18 million e-cigarette users in the U.S., indicating significant market potential.
- Leadership Confidence: New CEO Andrew D. Goldberg stated that the addition of these executives is one of the most consequential decisions of his tenure, reflecting Achieve's strategic positioning to tackle public health issues and enhancing confidence in the company's future growth.
See More
Achieve Life Sciences Q1 2026 Earnings Beat Expectations
- Strong Earnings Report: Achieve Life Sciences reported a Q1 GAAP EPS of -$0.19, beating market expectations by $0.11, indicating improvements in financial management that may boost investor confidence.
- Healthy Cash Position: As of March 31, 2026, the company had $29.3 million in cash, cash equivalents, and marketable securities, excluding estimated net proceeds of approximately $168.6 million from private placements, reflecting positive fundraising progress.
- Private Placement Announcement: Achieve Life Sciences announced a private placement of up to $354 million, which is expected to further strengthen the company's capital structure and provide funding for future R&D and market expansion.
- Market Reaction Analysis: Despite a recent sell-off, analysts maintain a 'Buy' rating, anticipating that the upcoming PDUFA and expansion into vaping cessation will present new growth opportunities for the company.
See More
Achieve Life Sciences to Report Q1 2026 Financial Results on May 12
- Earnings Announcement: Achieve Life Sciences will report its Q1 2026 financial results and provide a corporate update on May 12, 2026, at 8:30 AM EDT, which is expected to positively influence investor confidence.
- FDA Review 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 potential market launch.
- Market Demand Context: Approximately 25 million adults in the U.S. smoke, with tobacco use causing over 500,000 deaths annually, highlighting the urgent need for effective smoking cessation treatments, which cytisinicline aims to address.
- Clinical Research Outcomes: Cytisinicline has completed multiple clinical studies for smoking and vaping cessation, with successful Phase 3 results laying a strong foundation for future commercialization, potentially enhancing the company's competitive position in the market.
See More
