Bristol‑Myers Squibb announced that it will enroll additional patients in the ADEPT‑2 Phase 3 study of its antipsychotic Cobenfy for psychosis associated with Alzheimer’s disease. The decision follows a blinded review of site‑level data that identified irregularities at a small number of trial sites. Data from those sites were excluded from the primary analysis, and an independent interim analysis led the Data Monitoring Committee to recommend continuation to reach the original target enrollment.
The ADEPT‑2 study is a multicenter, randomized, double‑blind, placebo‑controlled trial that evaluates Cobenfy’s efficacy on the Neuropsychiatric Inventory‑Clinician Hallucinations and Delusions (NPI‑C H+D) score and the Clinical Global Impression‑Severity (CGI‑S) score. The primary endpoint is the change in NPI‑C H+D score, with CGI‑S and safety/tolerability as key secondary endpoints. The trial is expected to read out by the end of 2026, with additional data from ADEPT‑1 and ADEPT‑4 anticipated around the same time.
The irregularities that prompted the data exclusion involved deviations in data collection and patient monitoring at a handful of sites. By removing these data points, the company aimed to preserve the integrity of the statistical analysis while still maintaining sufficient power to detect a clinically meaningful effect. The Data Monitoring Committee’s recommendation to continue indicates that the interim data did not reveal any critical safety concerns and that the efficacy signal, though modest, was encouraging enough to justify additional enrollment.
A successful readout could position Cobenfy as the first treatment in a new class of muscarinic receptor agonists for Alzheimer’s psychosis, a condition with no approved indication and a large unmet medical need. The drug’s approval would add a new revenue stream to BMS’s neuroscience portfolio, which was significantly strengthened by the 2023 acquisition of Karuna Therapeutics for $14 billion. The company’s strategy to focus on high‑impact neurological disorders is reinforced by the potential market opportunity for a first‑in‑class therapy in this indication.
Analysts have responded positively to the continuation decision. Scotiabank raised its price target for BMS to $53.00 from $45.00, citing the expected readouts from the ADEPT program in 2026. Truist Securities maintained a buy rating and a $65.00 price target, while William Blair kept a market‑perform rating. The consensus view is that the Data Monitoring Committee’s endorsement signals confidence in the trial’s safety profile and a potentially favorable efficacy trajectory.
Laura Gault, Senior Vice President of Neuroscience Drug Development at BMS, said, “We agree with the decision made in consultation with the FDA and the Data Monitoring Committee to continue the Phase 3 study and will move forward with recruiting additional patients. Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies. Psychosis related to Alzheimer’s Disease remains an area of tremendous unmet medical need, and maintaining rigorous standards is essential as we work to identify innovative treatment options for patients and families affected by this devastating condition.”
The company will continue to monitor safety and efficacy data closely as enrollment expands. The readout, expected by the end of 2026, will determine whether Cobenfy can secure regulatory approval for Alzheimer’s psychosis and potentially open a new therapeutic class for BMS’s neuroscience pipeline.
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