New life sciences executive brings more than 25 years of legal expertise spanning clinical and commercial stage biopharmaceutical companiesSEATTLE and VANCOUVER, British Columbia, Oct. 20, 2025 (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 the appointment of Erik Atkisson as Chief Legal Officer. In ...

Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program SEATTLE and VANCOUVER, British Columbia, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced ...

SEATTLE and VANCOUVER, British Columbia, Oct. 02, 2025 (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 effective October 1, 2025, Achieve’s board of directors approved stock option grants to purchase an aggregate of 161,000 shares of its common stock for five new employees under Achieve’s 2024 E ...

SEATTLE and VANCOUVER, British Columbia, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as treatment of nicotine dependence, today announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD). The Thorax pub ...

Core Insights - Achieve Life Sciences, Inc. has appointed Mark Rubinstein, M.D. as Interim Chief Medical Officer, succeeding Cindy Jacobs, Ph.D., M.D. [1][3] - The company is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent FDA acceptance of its New Drug Application [3][4] - Cytisinicline is positioned as a potential treatment for the estimated 15 million American adults who attempt to quit smoking each year [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company dedicated to addressing the global nicotine dependence epidemic through cytisinicline [4] - The FDA has set a PDUFA completion date of June 20, 2026, for the cytisinicline New Drug Application [4] - The company has completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [4] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [5] - There are around 17 million adults in the U.S. who use e-cigarettes, and no FDA-approved treatments currently exist specifically for nicotine e-cigarette cessation [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need in nicotine dependence treatment [5][6]

Core Insights - Achieve Life Sciences has received FDA acceptance for its New Drug Application (NDA) for cytisinicline, marking a significant step towards potentially the first new FDA-approved pharmacotherapy for smoking cessation in two decades, with a PDUFA target date set for June 20, 2026 [2][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline to address nicotine dependence and smoking cessation [5]. - The company has conducted extensive research, with over 2,000 clinical trial participants contributing to the evidence supporting cytisinicline's efficacy [3]. Clinical Trials and Efficacy - The ORCA-2 and ORCA-3 Phase 3 clinical trials demonstrated that cytisinicline, administered for either 6 or 12 weeks alongside standard behavioral support, resulted in significantly higher smoking abstinence rates compared to placebo [3]. - Safety data from the trials included over 400 participants with at least six months of cumulative exposure to cytisinicline, showing no new safety concerns [3]. Public Health Impact - Smoking is the leading cause of preventable death in the U.S., claiming nearly half a million lives annually and costing the economy over $600 billion each year [4][6]. - Approximately 15 million Americans attempt to quit smoking each year, highlighting the need for effective cessation tools [4]. Market Opportunity - There are about 29 million adults in the U.S. who smoke combustible cigarettes, and the company aims to provide a new treatment option for this population [6]. - Additionally, there are around 17 million adults using e-cigarettes, with no FDA-approved treatments currently available for nicotine e-cigarette cessation, indicating a significant unmet need [7]. Product Mechanism - Cytisinicline is a plant-derived alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [8].

Core Viewpoint - Achieve Life Sciences Inc. is approaching a critical phase as it seeks FDA approval for cytisinicline, a potential new smoking cessation therapy, with a commercial launch anticipated in 2026 [1][8]. Company Developments - In June, Achieve Life Sciences submitted a New Drug Application (NDA) to the FDA for cytisinicline aimed at nicotine dependence for smoking cessation in adults [2]. - The NDA is backed by positive efficacy and safety results from two Phase 3 trials, ORCA-2 and ORCA-3, which showed significant improvements in abstinence rates compared to placebo [3][4]. Financial Aspects - The company raised approximately $45 million in June to support the advancement of cytisinicline through potential FDA marketing approval and for general corporate purposes, with funding expected to last into the second half of 2026 [5]. Market Potential - Analyst Brandon Folkes believes the next 12 to 18 months could represent a significant value inflection point for ACHV stock, as the current share price does not reflect the commercial potential of cytisinicline [6]. - Cytisinicline is positioned to address the shortcomings of existing therapies, with a potential pricing strategy ranging from $500 to $3,000 per month, justified by the economic costs of smoking [8]. Competitive Landscape - Cytisinicline's tolerability is highlighted as a key advantage over Pfizer's Chantix, which has faced usage limitations due to side effects [7]. - The global market for smoking cessation therapies is valued at $13 billion, with the potential for cytisinicline to capture a significant share, especially considering the previous success of Chantix, which generated nearly $1 billion annually in U.S. sales before its withdrawal [9].

Financial Data and Key Metrics Changes - Achieve Life Sciences closed the second quarter with a strengthened balance sheet following a successful $45 million public offering in June, which included common stock and warrants [29] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $55.4 million, expected to support operations into 2026 [29] - Total operating expenses for the three and six months ended June 30, 2025, were $12.6 million and $25.5 million respectively, consistent with expectations as the company increased investment in regulatory and pre-commercial planning [30] - The net loss for the same periods was $12.7 million and $25.5 million respectively [30] Business Line Data and Key Metrics Changes - The company achieved three transformative milestones: the submission of a new drug application (NDA) for cytisinicline, a strategic partnership with Omnicom, and a capital raise of $49 million [5][6] - The NDA submission is supported by data from over 2,000 clinical trial participants, including results from two Phase III studies and long-term safety data [12][13] Market Data and Key Metrics Changes - There are approximately 29 million smokers in the U.S., with over 15 million attempting to quit each year, highlighting a significant market opportunity for cytisinicline [7] - The annual cost of smoking-related health issues in the U.S. is over $600 billion, indicating a substantial public health burden [8] Company Strategy and Development Direction - The company aims to change the narrative around nicotine dependence, positioning it as a medical condition that requires effective treatment options [7][24] - Achieve is focused on a data-driven approach to its commercial launch strategy, leveraging a proprietary AI-enabled platform for decision-making and performance optimization [19][26] - The strategic partnership with Omnicom is intended to enhance brand development, market access, and stakeholder engagement ahead of the product launch [18][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process and anticipates receiving the FDA's Day 74 NDA acceptance letter in mid-September [31] - The company is committed to executing its strategy with financial prudence while preparing for a potential product launch in late 2026 [31][32] - Management highlighted the importance of building relationships with payers to ensure rapid access to cytisinicline following approval [22][23] Other Important Information - The company plans to complete the ORCA-OL study database by the end of the year and aims to present the results in 2026 [15][68] - Achieve is actively engaging with the FDA and has requested a priority review for the NDA submission, although a standard review is currently anticipated [50] Q&A Session Summary Question: Will the 120-day safety update include only 100 patients or the full 290? - The company will submit all subjects available at the time of the database cut, which will be more than 100 but not the full 290 [34] Question: How will commercial spending ramp up ahead of launch? - The company will incrementally increase pre-commercial activities prior to approval, with a disciplined approach to commercial investment [35][36] Question: Will cytisinicline be priced at a premium compared to generic options? - The company views cytisinicline as a branded product at a premium price, supported by its differentiated profile [37] Question: What initial contact methods will be used to reach providers? - The company plans to identify individual needs of targeted physicians and engage through various channels, including social media and email [40][42] Question: What is the overall safety profile of cytisinicline? - The safety profile remains consistent with previous data, with no new safety signals identified [46][47] Question: Will there be any updates on future clinical development before the end of the year? - The company plans to complete the ORCA-OL study database quickly and aims to present data at conferences in 2026 [66][68]

Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) for cytisinicline to the FDA, marking a significant milestone in the development of a new treatment for nicotine dependence [4][12] - The company has established a partnership with Omnicom to create a data-driven commercialization strategy for the potential launch of cytisinicline in the U.S. [5] - Achieve completed a public offering raising $49.3 million to support the advancement of cytisinicline and general corporate purposes [6][7] Financial Performance - As of June 30, 2025, Achieve reported cash, cash equivalents, and marketable securities totaling $55.4 million [10] - Total operating expenses for the second quarter of 2025 were $12.6 million, with a net loss of $12.7 million for the quarter [10][19] - The company raised gross proceeds of $45 million from an underwritten public offering, which included 15 million shares of common stock and accompanying warrants [6] Clinical Development - The NDA submission is supported by positive results from Phase 3 ORCA-2 and ORCA-3 trials, which demonstrated significantly higher quit rates with cytisinicline compared to placebo [4] - Achieve has met the FDA's long-term safety requirements for cytisinicline, with over 300 participants completing at least six months of treatment [8] - The Phase 3 ORCA-3 trial results were published in JAMA Internal Medicine, confirming the efficacy and tolerability of cytisinicline for smoking cessation [9] Market Opportunity - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, with smoking being the leading cause of preventable death [13] - Cytisinicline has the potential to address a critical unmet public health need, especially given the nearly half a million smoking-related deaths annually in the U.S. [4][13] - The partnership with Omnicom aims to leverage a unified, AI-enabled launch platform to optimize the commercialization process for cytisinicline [5]

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [3] - The company submitted its New Drug Application to the FDA for cytisinicline in June 2025, based on two completed Phase 3 studies and a fully enrolled open-label safety study [3] - Achieve has also completed a Phase 2 study for cytisinicline in vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Industry Context - Approximately 29 million adults in the United States smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over 8 million deaths worldwide and nearly 500,000 deaths annually in the U.S. [4] - More than 87% of lung cancer deaths, 61% of pulmonary disease deaths, and 32% of coronary heart disease deaths are attributable to smoking and secondhand smoke exposure [4] - There are around 17 million adults in the U.S. who use e-cigarettes, with 1.6 million middle and high school students reporting e-cigarette use in 2024 [4] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors, believed to aid in treating nicotine addiction by reducing craving symptoms and the satisfaction associated with nicotine products [5] - Cytisinicline is currently an investigational product candidate and has not yet been approved by the FDA for any indication in the United States [5] - The FDA has granted Breakthrough Therapy designation to cytisinicline to address the critical need for treatments specifically aimed at nicotine e-cigarette cessation [4]