Achieve Life Sciences, Inc.(ACHV)Earnings, Financials & Key Ratios

SEATTLE and VANCOUVER, British Columbia, June 29, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced that it has been added to the Russell 2000® Index, effective June 26, 2026, as part of the Russell U.S. Indexes reconstitution. The Company is also a member of the Russell 3000® Index.

Achieve Life Sciences remains a cytisinicline story, with very positive smoking-cessation data. This also gives cytisinicline some added optionality for vaping. The FDA's CRL appears to be mostly about manufacturing and labeling issues. However, it's not about a particular cytisinicline efficacy or safety problem. ACHV is currently targeting Q4 2026 resubmission and, assuming everything goes according to plan, it could receive approval by 1H2027.

Achieve Life Sciences Inc. (NASDAQ:ACHV) on Monday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application seeking approval of cytisinicline, its investigational treatment for nicotine dependence.

The U.S. Food and Drug Administration ​has declined to approve Achieve Life ‌Sciences' drug to treat nicotine dependence in adults, the company said on Monday.

CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA's action date.