Bristol Myers Extends Key Alzheimer’s Drug Trial

Bristol Myers extends its key Cobenfy trial in Alzheimer's psychosis after finding data 'irregularities,' delaying results to 2026.

Bristol Myers Squibb has announced a significant extension of its pivotal Phase 3 "ADEPT-2" trial for Cobenfy (bms-986445) in Alzheimer’s disease psychosis, following the discovery of unspecified data "irregularities." The delay pushes anticipated results into 2026, dashing hopes for a year-end data readout that analysts had projected as a major catalyst event for the company. This setback highlights the immense complexity and high stakes of neurology trials, particularly in Alzheimer's, where patient heterogeneity and endpoint measurement pose persistent challenges for drug development.

This unplanned extension starkly contrasts with the streamlined, on-schedule execution that investors reward. The vague "irregularities" cite points to potential issues with data integrity or trial conduct that require thorough investigation, a process that can undermine confidence. This matters because it injects substantial regulatory risk into a program targeting a multibillion-dollar market with high unmet need. Bristol Myers is now tasked with assuring regulators and the market of the trial's ultimate validity, a process that will delay both potential approval and the competitive race against rivals like Acadia Pharmaceuticals.

For biotech investors and pharmaceutical executives, this delay is a sobering reminder of clinical trial volatility. It necessitates a reassessment of the drug's commercial timeline and competitive positioning. The forward-looking insight is clear: the path to treating Alzheimer's neuropsychiatric symptoms remains fraught with operational and scientific peril. This event will increase scrutiny on trial design and data management processes across the neurology sector, potentially leading to more conservative trial timelines and increased investment in decentralized trial technologies to enhance data quality and monitoring.