Full Press Release Details
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
• 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