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Achieve Life Sciences Announces FDA Accepted Cytisinicline New Drug Application To Treat Nicotine Dependence; PDUFA Date Set For June 20, 2026

Author: Benzinga Newsdesk | November 06, 2025 07:31am

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, today announced its financial results for third quarter 2025 and confirmed its Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026, for cytisinicline for treatment of nicotine dependence for smoking cessation.

  • Announced the U.S. Food and Drug Administration (FDA) accepted the cytisinicline New Drug Application (NDA) for treatment of nicotine dependence for smoking cessation in adults. The FDA assigned a PDUFA targeted action date of June 20, 2026.

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