Achieve Life Sciences Reports Q1 2025 Results

Achieve Life Sciences ( (ACHV) ) has released its Q1 earnings. Here is a breakdown of the information Achieve Life Sciences presented to its investors.

Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence and smoking cessation. In its first-quarter 2025 earnings report, Achieve Life Sciences announced plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025, marking a significant milestone in its development pipeline. The company highlighted the publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine, which demonstrated cytisinicline’s efficacy and tolerability in smoking cessation. Additionally, the ORCA-OL long-term exposure trial met FDA requirements, showing no safety concerns with extended cytisinicline use. Financially, Achieve reported a net loss of $12.8 million for the quarter, with operating expenses totaling $12.9 million. Looking ahead, Achieve Life Sciences remains focused on advancing cytisinicline through regulatory review, aiming to provide a new treatment option for smoking cessation in the U.S.