Bristol Myers Squibb Delays Cobenfy Alzheimer's Psychosis Trial Results to 2026 Following Site Irregularities
Key Insights
Bristol Myers Squibb (search) has delayed results from its Phase III ADEPT-2 trial of Cobenfy in Alzheimer's psychosis (search) to the end of 2026 after identifying irregularities at a small number of study sites.
The FDA and an independent data monitoring committee recommended continuing the trial with additional patient enrollment after excluding data from affected sites.
The delay affects a highly anticipated readout for a significant market opportunity, with an estimated 1.75 to 3.5 million Americans experiencing psychosis (search) related to Alzheimer's disease (search).
Bristol Myers Squibb (search) has pushed back the anticipated data readout from its Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) in Alzheimer's psychosis (search) to the end of 2026, following the discovery of irregularities in trial conduct at a small number of study sites.
The pharmaceutical company disclosed Wednesday that it had identified these irregularities during a review of its near-term clinical trials aimed at ensuring "timely delivery" of results with the "highest probability of success." After consulting with the FDA, Bristol Myers brought in an independent party to assess the collected data and excluded patient data from the affected sites from the primary analysis.
FDA and Data Monitoring Committee Support Continuation
Following the independent assessment, a data monitoring committee recommended that the trial continue and enroll additional participants to reach its original target. ADEPT-2 had recruited approximately 400 patients across 119 locations, according to its federal clinical trials database listing.
"BMS agrees with the decision made in consultation with the FDA and DMC to continue the Phase III study and will move forward with recruiting additional patients," said Dr. Laura Gault, head of development in neuroscience at Bristol Myers. "Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies."
Significant Market Opportunity at Stake
The delay affects a highly anticipated readout for what analysts consider a substantial market opportunity. Roughly 7 million people in the U.S. have Alzheimer's disease (search), and estimates suggest between a quarter and a half experience related psychosis (search), representing approximately 1.75 to 3.5 million potential patients.
William Blair analyst Matt Phipps noted that the readout is "highly anticipated by investors" in part because of the "size of the market opportunity." The trial was originally expected to deliver results before the end of this year.
Mixed Investor Response
Despite typical stock sell-offs following clinical delays, Bristol Myers shares rose almost 5% to $50.60 by mid-morning Wednesday. Phipps suggested investors may view the FDA and data monitoring committee's go-ahead as a positive sign, writing, "[I]f there was no signal, why bother increasing enrollment?"
However, Carter Gould of Cantor Fitzgerald expressed a more cautious view, suggesting the stock gain reflects that "no news" or "delayed news" is better than negative results. "While there's clearly a scenario whereby ADEPT-2 could still [succeed], none of this suggests an overwhelmingly positive result, and all of our past issues with this trial and setting remain," he noted.
Broader Context for Bristol Myers
The delay comes as Bristol Myers faces significant patent losses on its top-selling drugs Eliquis and Opdivo over the next couple of years. Prior to Wednesday, the company's shares had fallen 15% from the start of the year as efforts to offset these looming losses have shown mixed results.
Cobenfy, acquired through Bristol Myers' $14 billion buyout of Karuna Therapeutics (search) in 2023, gained FDA approval for schizophrenia (search) treatment in September 2024. However, the drug suffered a setback in April when a 400-person schizophrenia study found it not significantly better than placebo as an add-on treatment to atypical antipsychotics. Sales of Cobenfy across the first nine months of this year totaled $105 million.
Additional Alzheimer's Psychosis Studies Ongoing
Two other large trials, ADEPT-1 and ADEPT-4, are evaluating Cobenfy's use in Alzheimer's psychosis (search) and are expected to deliver data next year. The drug is also being investigated in bipolar disorder (search), with a Phase III trial planned to read out in 2027.
GlobalData's patient-based forecast predicts that Cobenfy will achieve blockbuster status in 2027, with 2031 sales projected to reach $2.36 billion.