ACHV

The last months were eventful for Achieve Life Sciences, sending the stock strongly down, but later to a new high for the year, implying optimism about the future path. Achieve is, in my view, a more derisked case now, thanks to successful financing, progress on shifting its supply chain, and new leadership. Despite the CRL, ACHV continues to advance. The denial was not drug-related, pointing towards a possible successful outcome in this story.

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.

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.

Appointments Add Deep Biopharmaceutical Commercial Strategy, Clinical and Finance Expertise as Company Advances Toward Potential Cytisinicline Approval and Launch Appointments Add Deep Biopharmaceutical Commercial Strategy, Clinical and Finance Expertise as Company Advances Toward Potential Cytisinicline Approval and Launch

ORCA-OL data complete the clinical evidence package supporting the cytisinicline smoking cessation NDA No new safety signals identified by the independent Data Safety Monitoring Committee over 52 weeks of continuous exposure Nausea — a common barrier to treatment adherence with smoking cessation therapies — was reported in only 2.5% of participants over 52 weeks of continuous exposure¹ SEATTLE and VANCOUVER, British Columbia, May 19, 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 the presentation of comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting. Additional cytisinicline data will be presented at ATS on May 20.

Achieve Life Sciences (ACHV) is downgraded to 'Hold' due to anticipated CRL of cytisinicline for smoking cessation and NDA resubmission in Q4 2026. FDA inspection issues at a third-party manufacturer will trigger a Complete Response Letter on or before June 20,2026, pushing NDA resubmission to Q4 2026 and potential launch H1 2027. Company has shifted cytisinicline supply to Adare, but future FDA inspections at Adare's facility remain a key risk for approval timelines.

Achieve Life Sciences, Inc. (ACHV) Q1 2026 Earnings Call Transcript

Achieve Life Sciences NASDAQ: ACHV used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027.