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Cytisinicline

Nicotine Dependence for Smoking Cessation (Adults)

NDA SubmittedUnder FDA Review. PDUFA date June 20, 2026.

Key Facts

Indication
Nicotine Dependence for Smoking Cessation (Adults)
Phase
NDA Submitted
Status
Under FDA Review. PDUFA date June 20, 2026.
Company

About Achieve Life Sciences

Achieve Life Sciences is a publicly traded, late-stage biopharmaceutical company focused on developing and commercializing cytisinicline, a novel treatment for nicotine dependence. The company's New Drug Application (NDA) for smoking cessation was accepted by the FDA in September 2025, with a key decision date set for June 2026. With a dual headquarters in Bothell, Washington, and Vancouver, British Columbia, Achieve is targeting a massive market opportunity driven by the significant unmet medical need and the staggering healthcare costs associated with smoking.

View full company profile

About Achieve Life Sciences

Achieve Life Sciences is a publicly traded, late-stage biopharmaceutical company focused on developing and commercializing cytisinicline, a novel treatment for nicotine dependence. The company's New Drug Application (NDA) for smoking cessation was accepted by the FDA in September 2025, with a key decision date set for June 2026. With a dual headquarters in Bothell, Washington, and Vancouver, British Columbia, Achieve is targeting a massive market opportunity driven by the significant unmet medical need and the staggering healthcare costs associated with smoking.

View full company profile