Bristol Myers Squibb Delays Cobenfy Alzheimer’s Psychosis Trial Readout Due to Site Irregularities
Bristol Myers Squibb has postponed the results of its Phase III ADEPT-2 trial evaluating Cobenfy in Alzheimer's psychosis until the end of 2026 due to irregularities found at trial sites.12
The delay follows a need to address and investigate these site irregularities before finalizing data and reporting outcomes.12
Cobenfy is currently approved for treating schizophrenia in adults and is being studied to potentially become the first treatment in a new class for Alzheimer's psychosis.3
Despite the delay, Bristol Myers Squibb is continuing patient enrollment in the ADEPT-2 study to further investigate Cobenfy's efficacy in this population.4
The postponement means Bristol Myers Squibb will enter 2026 without the anticipated readout that could serve as a comeback for Cobenfy following a previous trial setback earlier in 2025.2
Sources:
1. https://trial.medpath.com/news/ef1933d6b64f70fd/bristol-myers-squibb-delays-cobenfy-alzheimer-s-psychosis-trial-results-to-2026-following-site-irregularities
2. https://www.fiercepharma.com/pharma/site-irregularities-bristol-myers-delays-key-cobenfy-readout-alzheimers-psychosis
3. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Continuation-of-ADEPT-2-Phase-3-Study-in-Psychosis-Associated-with-Alzheimers-Disease/default.aspx
4. https://www.psychiatrictimes.com/view/view/delay-on-cobenfy-alzheimer-disease-psychosis-data-following-phase-3-study-irregularities-new-patients-enrolled