Achieve Life Sciences is developing cytisinicline for use as a smoking cessation treatment in the United States and rest of world. Pivotal studies have been completed with safety & efficacy results exceeding expectations. Achieve is now awaiting its target action date of June 20th 2026 and preparing for commercialization. It has hired Omnicom and its family of businesses to help execute its plan. Existing cessation products provide limited effectiveness and produce unpleasant side effects including nausea, vivid dreams, insomnia & GI issues. Cytisinicline may fill a void in the prescription & NRT market by reducing nicotine cravings, severity of withdrawal & reward associated with smoking along with fewer side effects & shorter treatment duration. There are almost 40 million smokers in the US and over 1 billion globally, providing a substantial population demanding an improved smoking cessation product. We anticipate a 2026 commercialization of cytisinicline.

22 Sep 2025
ACHV: Preparations Continue as PDUFA Date Assigned

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ACHV: Preparations Continue as PDUFA Date Assigned
Achieve Life Sciences, Inc. (ACHV:NAS) | 0 0 0.0%
- Published:
22 Sep 2025 -
Author:
John Vandermosten -
Pages:
7 -
Achieve Life Sciences is developing cytisinicline for use as a smoking cessation treatment in the United States and rest of world. Pivotal studies have been completed with safety & efficacy results exceeding expectations. Achieve is now awaiting its target action date of June 20th 2026 and preparing for commercialization. It has hired Omnicom and its family of businesses to help execute its plan. Existing cessation products provide limited effectiveness and produce unpleasant side effects including nausea, vivid dreams, insomnia & GI issues. Cytisinicline may fill a void in the prescription & NRT market by reducing nicotine cravings, severity of withdrawal & reward associated with smoking along with fewer side effects & shorter treatment duration. There are almost 40 million smokers in the US and over 1 billion globally, providing a substantial population demanding an improved smoking cessation product. We anticipate a 2026 commercialization of cytisinicline.