Nasdaq

Achieve Life Sciences Reports No Safety Concerns in ORCA-OL Trial, Confirms NDA Submission Plans for Cytisinicline in Q2 2025

Achieve Life Sciences has announced that the Data Safety Monitoring Committee (DSMC) found no safety concerns during its second review of the ORCA-OL trial, which assesses the long-term exposure of ...
Nasdaq

Achieve Life Sciences Announces Planned NDA Submission for Cytisinicline Targeting End of Q2 2025

Achieve Life Sciences, Inc. announced its financial results for Q4 and the year-end 2024, while reaffirming plans to submit a new drug application (NDA) for cytisinicline, a treatment for nicotine ...
Seeking Alpha

Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation

More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s efficacy, safety, and tolerability profile SEATTLE and VANCOUVER, ...
Morningstar

Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission

Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission ORCA-OL Long-Term Exposure ...
Seeking Alpha

Achieve Life Sciences targets NDA submission for cytisinicline in June 2025 as open label study hits key milestones

CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...