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 ...

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].

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]

Core Viewpoint - Achieve Life Sciences, Inc. has successfully closed a public offering of 15 million shares of common stock, raising gross proceeds of $45 million to advance the development of cytisinicline for nicotine dependence treatment [1][2]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence, with a New Drug Application submitted to the FDA in June 2025 [5]. - The company has completed two Phase 3 studies and an open-label safety study for cytisinicline, and has also conducted a Phase 2 study for vaping cessation [5]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction derived from nicotine products [7]. - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally, with over 8 million deaths annually [6]. - There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [6]. Financial Details - The public offering included 15 million shares at a price of $3.00 per share, along with warrants to purchase up to 16,766,666 additional shares [1]. - Proceeds from the offering will be used for advancing cytisinicline towards FDA marketing approval and for general corporate purposes [2].

Core Viewpoint - Achieve Life Sciences, Inc. is conducting a public offering of 15 million shares of common stock and accompanying warrants at a price of $3.00 per share, aiming to raise approximately $45 million to support the development of cytisinicline for nicotine dependence treatment [1][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence and smoking cessation [7]. - The company submitted a New Drug Application to the FDA for cytisinicline in June 2025, based on successful Phase 3 studies and an open-label safety study [7]. Offering Details - The public offering includes 15 million shares and warrants, with an additional 2.25 million shares available for underwriters to purchase [1][3]. - Each common warrant can be exercised for common stock at $3.00 or for pre-funded warrants at $2.999, expiring five years from issuance [2]. Financial Aspects - The gross proceeds from the offering are expected to be around $45 million, which will be used for advancing cytisinicline towards FDA approval and for general corporate purposes [4]. - The offering is expected to close around June 30, 2025, pending customary closing conditions [3]. Market Context - There are approximately 29 million adult smokers in the U.S., with tobacco use being the leading cause of preventable death [8]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the need for effective treatments for nicotine e-cigarette cessation, as there are currently no FDA-approved options for this indication [9].

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 [5] - 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 [5] Offering Details - Achieve Life Sciences announced a proposed underwritten public offering to sell shares of its common stock and accompanying common warrants, with an option for underwriters to purchase an additional 15% of the shares [1][2] - The proceeds from the offering are intended to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital and general corporate purposes [2] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over eight million deaths globally and nearly half a million in the U.S. annually [6] - There are around 17 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need for effective solutions [7] 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 [8][9] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the urgent need for treatments for nicotine dependence [7]

Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) to the FDA for cytisinicline, marking the first new pharmacotherapy option for nicotine dependence in two decades [1][4] - Cytisinicline has shown efficacy and safety in two large Phase 3 trials, ORCA-2 and ORCA-3, demonstrating significantly higher abstinence rates compared to placebo [2][3] - The public health burden of smoking affects nearly 29 million adults in the U.S., with smoking-related illnesses causing nearly half a million deaths annually [2][5] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment [4] - The company has also completed a Phase 2 study for vaping cessation and has received Breakthrough Therapy designation from the FDA for cytisinicline [6][4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, potentially reducing nicotine cravings and satisfaction from nicotine products [7] - The NDA submission is supported by data from over 2,000 clinical trial participants, indicating a well-tolerated safety profile [1][2]

Core Insights - Achieve Life Sciences is presenting additional analyses from its Phase 3 ORCA-3 study on cytisinicline at the 2025 ATS International Conference, emphasizing its dual mechanism of action in treating nicotine dependence [1][8] - Cytisinicline has shown significant efficacy in reducing nicotine cravings and intake, even among smokers who do not completely quit, indicating its potential as a therapeutic option for smoking cessation [3][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation, having completed two Phase 3 studies and one Phase 2 study for vaping cessation [7] - The company plans to submit a New Drug Application for cytisinicline in June 2025, aiming to address the smoking health epidemic affecting millions [6][7] Clinical Findings - The ORCA-3 study demonstrated a significant reduction in craving scores (p=0.0001) and serum cotinine levels among participants treated with cytisinicline compared to placebo, with a reduction equivalent to nearly four times more in cotinine levels [4][5] - Cytisinicline's dual action as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor may help smokers reduce their nicotine intake while on the path to quitting [3][5] Market Context - There are approximately 29 million adult smokers in the U.S., with smoking being the leading cause of preventable death, highlighting the critical need for effective cessation treatments [9] - Cytisinicline has received Breakthrough Therapy designation from the FDA, indicating its potential to address the urgent need for effective nicotine cessation therapies [10][11]