Achieve life sciences announces fda acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation

Filing based on pivotal phase 3 orca-2 and orca-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation fda acceptance starts the review process and sets timing for potentially the first new fda-approved pharmacotherapy in two decades pdufa targeted date set for june 20, 2026 seattle and vancouver, british columbia, sept. 03, 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, today announced that the u.s. food and drug administration (fda) has accepted the cytisinicline new drug application (nda) for a new treatment for smoking cessation in adults.
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