Achieve Life Sciences

ACHV

Market cap $165M

SEATTLE and VANCOUVER, British Columbia, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced that effective October 1, 2025, Achieve's board of directors approved stock option grants to purchase an aggregate of 161,000 shares of its common stock for five new employees under Achieve's 2024 Equity Inducement Plan.

New data address critical treatment gap for millions of Americans with COPD who face unique smoking cessation challenges New data address critical treatment gap for millions of Americans with COPD who face unique smoking cessation challenges

Donnelly brings more than 25 years of biopharmaceutical expertise in CMC and regulatory operations Donnelly brings more than 25 years of biopharmaceutical expertise in CMC and regulatory operations

SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced Mark Rubinstein, M.D., will assume the role of Interim Chief Medical Officer (CMO). Dr. Rubinstein will succeed Cindy Jacobs, Ph.D., M.D., who we anticipate will provide advisory services to support the company's ongoing efforts to advance cytisinicline as a potential treatment option for nicotine dependence.

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, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence, today announced that the U.S. Food and Drug Administration (FDA) has accepted the cytisinicline New Drug Application (NDA) for a new treatment for smoking cessation in adults.

SEATTLE and VANCOUVER, British Columbia, Sept. 02, 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 a treatment of nicotine dependence for smoking cessation, today announced that Rick Stewart, CEO of Achieve Life Sciences, will be participating at two upcoming conferences. Details are as follows:

Achieve Life Sciences Inc. ACHV is moving closer to a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades, positioning the company for a high-stakes commercial launch in 2026.

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q2 2025 Earnings Call August 7, 2025 8:30 AM ET Company Participants Cindy Jacobs - Former President & Chief Medical Officer Jaime Xinos - Chief Commercial Officer Mark K. Oki - Chief Financial Officer Nicole Jones - Corporate Participant Richard A.

Achieve (ACHV) Q2 Net Loss Hits $12.7M

SEATTLE and VANCOUVER, British Columbia, Aug. 07, 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 a treatment of nicotine dependence for smoking cessation, today announced its financial results for second quarter 2025. “This quarter represents a significant step forward for Achieve.