Achieve Life Sciences announces FDA acceptance of cytisinicline NDA

Achieve Life Sciences (ACHV) 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. The FDA has assigned a Prescription Drug User Fee Act, PDUFA, targeted action date of June 20, 2026. “The FDA’s acceptance of our NDA validates the totality of our product development program,” said Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences. “Our application is supported by a decade of rigorous research and comprehensive data from thousands of participants. We’ve built compelling scientific and clinical results as a foundation that, if approved, positions cytisinicline to potentially address a significant medical need. We’re eager to engage constructively with the FDA as we progress through the NDA review process.”