Achieve Life Sciences, Inc. (ACHV)

In the past six months, Achieve Life Sciences' stock has experienced several notable events. As of February 6, 2026, the stock price gained 7.59% on the last trading day, rising from $3.95 to $4.25, but had fallen by 24.11% over the preceding 10 days. Despite recent fluctuations, the stock has gained approximately 34% year-to-date and about 31% over the past 12 months as of February 8, 2026. The company raised $45.0 million through a public offering in June 2025. The FDA accepted the company's NDA for cytisinicline in September 2025, with a PDUFA target action date of June 20, 2026. Achieve Life Sciences received a Commissioner's National Priority Voucher (CNPV) from the FDA in October 2025. The company reported its third-quarter earnings in November 2025, with an EPS of -$0.28, missing the expected -$0.24.

Demand for smoking cessation treatments exhibits seasonal variation. Total enrollments and visits for smoking cessation treatment are typically 20%-25% higher in January-April compared to June-September. Demand for such products may be stronger in the earlier part of the year.

Achieve Life Sciences, Inc. (ACHV) is a late-stage specialty pharmaceutical company focused on addressing nicotine dependence through the development and commercialization of cytisinicline. The company operates in the Healthcare sector, specifically the Biopharmaceutical industry, focusing on In Vitro & in Vivo Diagnostic Substances. Cytisinicline is a plant-based alkaloid designed to interact with nicotine receptors in the brain, aiming to reduce withdrawal symptoms and aid in smoking and vaping cessation. It has completed two Phase 3 trials for smoking cessation and a Phase 2 study for vaping cessation.

Achieve Life Sciences, Inc. has its principal executive offices in Bothell, Washington, and Vancouver, British Columbia. The company is focused on the development and commercialization of cytisinicline in Canada, the United States, and the United Kingdom.

Achieve Life Sciences' brand reputation over the past year appears to be generally positive, largely driven by the progress of cytisinicline. Analysts have given ACHV an average recommendation of "Moderate Buy," with an average twelve-month price target of $15.50 from five brokerages. Positive events contributing to its reputation include successful completion of Phase 3 trials for smoking cessation, FDA acceptance of the NDA for smoking cessation, receipt of a CNPV for vaping cessation, and publication of positive Phase 3 ORCA-3 trial results in JAMA Internal Medicine. The company is in a legal dispute with its original supplier, Sopharma, regarding cytisinicline supply. While currently funded through the second quarter of 2026, the company will likely need to raise additional capital to commercialize the drug after receiving approval, which could lead to shareholder dilution. The company has reported substantial net losses.

Approximately 26.82% of the company's stock is owned by institutional investors, 1.68% by insiders, and 71.50% by public companies and individual investors. Major institutional owners include Propel Bio Management, LLC, Simplify Propel Opportunities ETF (SURI), Vanguard Group Inc, Franklin Biotechnology Discovery Fund Class A (FBDIX), Vanguard Total Stock Market Index Fund Investor Shares (VTSMX), Simplify Asset Management Inc., Marshall Wace, Llp, Nantahala Capital Management, LLC, Vanguard Extended Market Index Fund Investor Shares (VEXMX), and Geode Capital Management, Llc.