Overview
- Bristol Myers excluded data from a small number of ADEPT-2 sites before database lock after identifying execution irregularities.
- Following consultation with the FDA, an independent interim efficacy and safety analysis was conducted and reviewed by the Data Monitoring Committee.
- The DMC recommended continuing the Phase 3 study and enrolling additional participants to reach the original target population.
- The company now guides to ADEPT program results by the end of 2026 and says it remains blinded to study data.
- Shares rose about 5% on the update, as the trial evaluates Cobenfy using NPI-C Hallucinations & Delusions as the primary endpoint and CGI-S as a key secondary measure.