Achieve Life Sciences

ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo» Mehr auf globenewswire.com

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q4 2024 Earnings Conference Call March 11, 2025 8:30 AM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jaime Xinos - Chief Commercial Officer Mark Oki - Chief Financial Officer Conference Call Participants Gary Nachman - Raymond James Thomas Flaten - Lake Street Capital Markets Francois Brisebois - Oppenheimer and Company Justin Walsh - Jones Trading Brandon Folkes - Rodman & Renshaw John Vandermosten - Zacks SCR Boris Tolkachev - Freedom Broker Operator Greetings, and welcome to the Achieve Life Sciences Fourth Quarter and Year-End 2024 Earnings Call and Webcast. At this time all participants are in a listen-only mode.» Mehr auf seekingalpha.com

Reiterates Planned Cytisinicline NDA Submission Expected at the End of Q2 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, March 11, 2025 SEATTLE and VANCOUVER, British Columbia, March 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 as a treatment of nicotine dependence for smoking cessation, today announced its financial results for the fourth quarter and year-end 2024 and reiterated its plans to submit its new drug application (NDA) for cytisinicline at the end of the second quarter of 2025. Recent Highlights Reached key milestones in the ORCA-OL long-term exposure trial, including completion of enrollment and meeting the requirement of 300 participants receiving six months of cumulative cytisinicline treatment, as required for the submission of the NDA Announced positive outcomes from two data safety monitoring committee (DSMC) reviews with no safety concerns in the ORCA-OL clinical trial Appointed Dr. Kristen Slaoui and Nancy Phelan to the Board of Directors, bringing extensive leadership experience in corporate strategy and commercialization Appointed Mark Oki as Chief Financial Officer to oversee the company's financial strategy and operational initiatives Announced the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for defining cytisinicline development as a treatment for vaping cessation “We are thrilled with our progress to date and excited to have the NDA submission on track for the end of next quarter, furthering our mission to bring cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years,” said Rick Stewart, Achieve's Chief Executive Officer.» Mehr auf globenewswire.com