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].