Achieve Life Sciences

ACHV

Market cap $259M

Achieve Life Sciences, Inc. ( ACHV ) Q3 2025 Earnings Call November 6, 2025 8:30 AM EST Company Participants Nicole Jones Richard A. Stewart - CEO & Executive Director Jaime Xinos - Chief Commercial Officer Mark Oki - Chief Financial Officer Jerry Wan - VP of Finance & Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets, LLC, Research Division Gary Nachman - Raymond James & Associates, Inc., Research Division Brandon Folkes - H.C.

One of Only Nine Therapies Chosen for the Inaugural FDA Commissioner's National Priority Voucher for E-cigarette or Vaping Cessation Conference Call Scheduled for 8:30 AM EST Today, November 6, 2025

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, Oct. 29, 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 it will report its third quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Thursday, November 6, 2025, at 8:30 AM EST.

New life sciences executive brings more than 25 years of legal expertise spanning clinical and commercial stage biopharmaceutical companies New life sciences executive brings more than 25 years of legal expertise spanning clinical and commercial stage biopharmaceutical companies

Achieve Life Sciences maintains its 'Buy' rating as the FDA accepts the NDA for cytisinicline for smoking cessation, with a PDUFA date set for June 20, 2026. ACHV's expansion into e-cigarette and vaping cessation is promising, supported by positive Phase 2 ORCA-V1 results and a Commissioner's National Priority Voucher from the FDA. Cytisinicline demonstrated a 2.6x higher quit rate vs. placebo in vaping cessation, and the FDA confirmed that a Phase 3 trial, plus ORCA-V1, could support an sNDA.

Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway

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