Achieve Life Sciences Submits Cytisinicline NDA to FDA for Smoking Cessation

Achieve Life Sciences has submitted a New Drug Application (NDA) to the FDA for cytisinicline, a plant-based treatment aimed at nicotine dependence and smoking cessation, marking the first potential new FDA-approved smoking cessation drug in 20 years. This submission is supported by positive results from Phase 3 trials, ORCA-2 and ORCA-3, which showed statistically significant improvements in smoking abstinence and urges compared to placebo, and additional long-term safety data from the ORCA-OL open-label study revealed no new safety concerns. The company has partnered with Omnicom to lead a data-driven commercial launch in the U.S. and recently priced an underwritten public offering to raise approximately $45 million to fund the continued advancement of cytisinicline and corporate purposes. Analysts have an average target price of $14.50 for Achieve Life Sciences stock, reflecting optimism about the drug's market potential, while acknowledging current financials showing operating expenses and net losses. With around 29 million adults in the U.S. who smoke, cytisinicline could fulfill a significant unmet need by providing a new pharmacotherapy option to help millions quit smoking. Achieve Life Sciences continues to collaborate closely with the FDA during the review process and aims to address the urgent public health challenge posed by smoking-related illnesses.