From GlobeNewswire: 2025-05-13 07:30:00

Achieve Life Sciences reaffirms plan to submit an NDA for cytisinicline to the FDA in June 2025. Financial results for Q1 2025 released. CEO Rick Stewart emphasizes potential public health impact of cytisinicline for smoking cessation.

Key highlights include the publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine, reaching FDA long-term exposure requirements, completion of third DSMC review, and a successful SAB meeting. Results show cytisinicline’s efficacy, safety, and tolerability for smoking cessation.

Conference call scheduled for today at 8:30 AM EDT. Financial results show cash reserves of $23.2 million as of March 31, 2025. Operating expenses for the quarter were $12.9 million, leading to a total net loss of $12.8 million. Achieve aims to address smoking health issues through cytisinicline development.

Cytisinicline, a potential treatment for smoking cessation, targets nicotine addiction by binding to nicotine receptors in the brain. Breakthrough Therapy designation granted by the FDA. Achieve aims to provide new treatment options for the 29 million U.S. adult smokers and 11 million e-cigarette users.

Achieve’s financials show total assets of $27.4 million as of March 31, 2025, with liabilities of $10.3 million. Loss from operations was $12.9 million for the quarter. Achieve focuses on advancing cytisinicline development for smoking and vaping cessation.



Read more at GlobeNewswire:: Achieve Life Sciences Reports First Quarter 2025 Financial