Achieve Life Sciences, Inc.
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- Achieve Life Sciences, Inc. (Nasdaq: ACHV) is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline, a plant-based alkaloid, as a treatment for nicotine dependence and smoking cessation; the company advances cytisinicline through its ORCA clinical program, including Phase 3 trials ORCA-2 and ORCA-3 demonstrating statistically significant smoking cessation rates, and the completed ORCA-OL open-label long-term safety study with over 330 participants exposed for one year. Cytisinicline targets nicotinic acetylcholine receptors to reduce nicotine withdrawal symptoms and cravings with potentially fewer side effects than existing therapies; it also pursues indications for e-cigarette and vaping cessation. Headquartered in Bothell, Washington, with operations in Vancouver, British Columbia, the company, founded in 2015, maintains license and supply agreements with Sopharma AD for cytisine production and the University of Bristol; it serves global markets including the United States, Canada, and the United Kingdom, targeting adult smokers and nicotine users amid the public health crisis of tobacco and vaping addiction. Recent developments include FDA acceptance in September 2025 of its New Drug Application for smoking cessation, submitted in June 2025 with a PDUFA target action date of June 20, 2026; receipt of the FDA Commissioner's inaugural National Priority Voucher for e-cigarette cessation, one of only nine therapies selected; submission of a 120-day safety update encompassing data from over 400 participants; a strategic partnership with Omnicom for data-driven commercial launch preparation; a $45 million underwritten public offering; $20 million loan refinancing with Silicon Valley Bank; leadership additions such as Mark Oki as CFO, Dr. Mark Rubinstein as Interim Chief Medical Officer and Head of Medical Affairs, and Jaime Xinos promotion to Chief Commercial Officer; and granting of inducement equity awards to support growth.
Company News
Achieve Life Sciences Appoints Kaitlyn Tuson as Senior Vice President, Marketing and Communications
Achieve Life Sciences Announces Granting of New Hire Inducement Awards
Achieve Life Sciences (NASDAQ:ACHV) Shares Gap Up – Here’s What Happened
Achieve Life Sciences Appoints Benjamin Halladay as Chief Financial Officer
Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026
Achieve Life Sciences: Thesis Intact, Setup Remains Constructive (Rating Downgrade)
Achieve Life Sciences: A Funded Manufacturing Reset, Not A Broken Clinical Thesis
Achieve Life Sciences, Inc. (NASDAQ:ACHV) Receives Consensus Rating of “Buy” from Brokerages
Frazier Life Sciences Management L.P. Buys New Stake in Achieve Life Sciences, Inc. $ACHV
Achieve Life Sciences Announced Granting of New Hire Inducement Awards
Deutsche Bank AG Makes New $506,000 Investment in Achieve Life Sciences, Inc. $ACHV
Achieve Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Updates
Achieve Life Sciences Appoints Ronald Dadino and Gloria Cosgrove to Lead CMC, Supply Chain, and Quality
Achieve Life Sciences Announced Granting of New Hire Inducement Awards
Achieve Life Sciences (NASDAQ:ACHV) Shares Up 6.5% – Here’s Why
Achieve Life Sciences Stockholders Weigh Board Slate, Share Increase at Annual Meeting
Achieve Life Sciences: Despite CRL, A Success Is Achieve-Able
Achieve Life Sciences Joins Russell 2000® Index
Achieve Life Sciences: CRL Is Fixable, So I Remain Bullish
FDA Declines To Approve Achieve Life Sciences' Smoking Cessation Drug; Q4 Resubmission Planned