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].

SEATTLE and VANCOUVER, British Columbia, June 26, 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 for smoking cessation, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying common wa ...

Smoking, the leading cause of preventable death and disease, continues to affect nearly 29 million adults in the U.S. alone If approved, cytisinicline will be the first new FDA-approved pharmacotherapy option for nicotine dependence in two decades More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s efficacy, safety, and tolerability profile SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (GLOBE NEWSWIRE) -- Achieve Life S ...

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]

Core Viewpoint - Achieve Life Sciences plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025, marking a significant milestone in the development of a new treatment for smoking cessation [1][2]. Company Developments - The company reported financial results for Q1 2025, with cash and equivalents totaling $23.2 million and a net loss of $12.8 million for the quarter [10][20]. - Achieve has successfully completed the FDA's long-term exposure requirements for cytisinicline, demonstrating safety data on over 300 participants completing six months and 100 participants completing one year of treatment [6][8]. - The company conducted a Science Advisory Board (SAB) meeting with leading experts to discuss clinical progress and NDA preparations [9]. Clinical Trial Results - The Phase 3 ORCA-3 trial results published in JAMA Internal Medicine confirmed cytisinicline's efficacy and tolerability, showing reduced nicotine cravings and extended quit rates through 24 weeks [5][8]. - In the ORCA-OL long-term exposure trial, 75% of the 479 enrolled participants remained on treatment, indicating the potential for cytisinicline to shift the treatment paradigm for smoking cessation [4][6]. Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, with tobacco use being the leading cause of preventable death [13]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA, addressing the critical need for effective treatments for nicotine dependence, including e-cigarette cessation [14][15].