From GlobeNewswire: 2025-03-11 07:30:00

Achieve Life Sciences plans to submit its NDA for cytisinicline at the end of Q2 2025. Recent highlights include reaching key milestones in the ORCA-OL trial, positive outcomes from DSMC reviews, and new board appointments. Achieve’s CFO Mark Oki will oversee financial strategy. The End-of-Phase 2 meeting with the FDA confirms cytisinicline’s development for vaping cessation. Financially, Achieve had $34.4 million in cash as of December 31, 2024, with a total net loss of $12.4 million for the quarter. They will host a conference call today at 8:30 AM EDT.

Achieve has reached key milestones in the ORCA-OL trial, including completing enrollment with 479 participants. Two positive DSMC reviews confirmed no unexpected adverse events and excellent participant adherence. Dr. Kristen Slaoui and Nancy Phelan have been appointed to the board, while Mark Oki is the new CFO. The End-of-Phase 2 meeting with the FDA confirmed plans for vaping cessation.

Cytisinicline, an investigational product candidate, has shown promise in treating nicotine addiction for smoking and vaping cessation. Achieve aims to address the global smoking health crisis with its development and commercialization efforts. The company has completed Phase 3 studies for smoking cessation and Phase 2 for vaping cessation, with plans to submit its NDA in Q2 2025.

Achieve Life Sciences reported a total net loss of $12.4 million for the quarter and $39.8 million for the year ended December 31, 2024. As of March 11, 2025, the company had 34,685,072 shares outstanding. Achieve will host a conference call at 8:30 AM EDT today to discuss these financial results and recent developments.



Read more at GlobeNewswire:: Achieve Life Sciences Reports Financial Results for Fourth