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.
Achieve Life Sciences Appoints Jeffrey Farrow and Reid Waldman, MD to Board of Directors
Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment
Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment
Achieve Life Sciences: 'Hold' On Expected CRL Cytisinicline And Q4 2026 NDA Resubmission
Achieve Life Sciences, Inc. (ACHV) Q1 2026 Earnings Call Transcript
Achieve Life Sciences Q1 Earnings Call Highlights
Achieve Life Sciences Strengthens Board and Commercial Leadership with Three Senior Appointments from Team Previously at Verona Pharma
Achieve Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Updates
Achieve Life Sciences to Announce First Quarter 2026 Financial Results and Host Conference Call and Webcast on May 12, 2026
Achieve Life Sciences, Inc. (NASDAQ:ACHV) Given Average Rating of “Buy” by Brokerages
Achieve Life Sciences Announces Appointment of Andrew D. Goldberg, MD, as Chief Executive Officer and to the Board of Directors
Achieve Life Sciences Announces Up to $354 Million Private Placement
Achieve Life Sciences Announces Operational Progress Including Completion of Technology Transfer to Adare Pharma Solutions
Achieve Life Sciences: The Recent Sell Off Skews The Outcomes
Achieve Life Sciences: Maintaining 'Buy' On Upcoming PDUFA And Expansion Into Vaping Cessation
Achieve Life Sciences Announces Publication in Nicotine & Tobacco Research Linking Cytisinicline's Receptor Selectivity to Low Nausea Rates and Favorable Tolerability
Achieve Life Sciences, Inc. (ACHV) Q4 2025 Earnings Call Transcript
Achieve Life Sciences Shareholders Are Encouraged to Reach Out to Johnson Fistel for More Information About Potentially Recovering Their Losses
Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
Achieve Life Sciences to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call and Webcast on March 24, 2026