Clinical Trial SuccessPositive results from the ORCA-2 and ORCA-3 Phase 3 studies met primary and secondary endpoints, supporting the treatment's efficacy and highlighting its potential for market success.
Financial HealthAchieve reported a strengthened balance sheet through financing, which extends the cash runway well into the future, indicating a solid financial position for sustained operations.
Regulatory MilestonesFDA alignment secures the next steps for Achieve to submit an NDA for cytisinicline, showcasing progress in the regulatory process and potential market approval.