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A pooled Phase 3 analysis of more than 1,600 people who smoke showed high quit rates; including among those who had previously not succeeded with other smoking cessation medications and regardless of the number of prior quit attempts. Late-breaking survey data from year-long ORCA-OL safety study highlight participant experience with extended cytisinicline use. SEATTLE and…

120-Day Safety Update Submitted to FDA. ORCA-OL Long-Term Safety Trial Successfully Concluded. DSMC Completes Final Review of Cytisinicline, Finds No Drug Safety Concerns. SEATTLE and VANCOUVER, British Columbia, November 3, 2025 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as…

Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway. One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program. SEATTLE and VANCOUVER, British Columbia, October 17, 2025 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development…

New data address critical treatment gap for millions of Americans with COPD who face unique smoking cessation challenges. SEATTLE and VANCOUVER, British Columbia, September 22, 2025 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as treatment of nicotine dependence, today…

Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation. FDA acceptance starts the review process and sets timing for potentially the first new FDA-approved pharmacotherapy in two decades. PDUFA targeted date set for June 20, 2026. SEATTLE and VANCOUVER, British Columbia, September 3, 2025 (GLOBE…