Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025
Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025
Recent Highlights
- Announced publication of the second Phase 3 ORCA-3 trial results in the Journal of American Medical Association (JAMA) Internal Medicine that evaluated cytisinicline for smoking cessation in 792 U.S. adults
- Reached key requirements in the ORCA-OL long-term exposure trial including safety exposure data for ≥300 participants receiving six months and at least 100 participants receiving one year of cumulative cytisinicline treatment
- Completed third safety review of the ORCA-OL clinical trial with the Data Safety Monitoring Committee (DSMC), which did not identify any safety concerns with longer-term cytisinicline exposure
- Conducted a Science Advisory Board (SAB) meeting with leading experts in nicotine and tobacco cessation research
Conference Call Details
Achieve will host a conference call at 8:30 am EDT today, Tuesday, May 13, 2025. To access the webcast, please use the following link: 1Q25 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International), referencing conference ID 13752599. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.
Achieve will host a conference call at 8:30 am EDT today, Tuesday, May 13, 2025. To access the webcast, please use the following link: 1Q25 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International), referencing conference ID 13752599. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.
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