Achieve Life Sciences is a pre-revenue, late-stage specialty pharmaceutical company focused on a single drug candidate: cytisinicline, a plant-derived alkaloid being developed as a prescription treatment for nicotine dependence. Cytisinicline works by binding to nicotinic receptors in the brain, reducing cravings and withdrawal symptoms while blocking the reward associated with nicotine use. Achieve has submitted an NDA to the FDA for smoking cessation, with a PDUFA date of June 20, 2026, and is planning a Phase 3 trial for a vaping cessation indication, for which the FDA has granted Breakthrough Therapy designation. Achieve plans to commercialize cytisinicline as a branded prescription drug in the U.S., targeting the roughly 29 million adult cigarette smokers and 17 million adult e-cigarette users. The company's commercial strategy is lean, relying on an AI-driven marketing platform built with Omnicom rather than a large internal sales force, with a focus on high-volume prescribers. If approved, cytisinicline would be the first new prescription smoking cessation drug in nearly 20 years. Achieve argues cytisinicline is differentiated from generic varenicline — the dominant prescription option — by a meaningfully better tolerability profile, flexible dosing, and no neuropsychiatric warning label. Achieve funds operations through equity raises and has no revenue until a successful launch, which management targets for the second half of 2026.