After delaying a late-stage readout last year due to “irregularities” at certain study sites, pivotal data for Bristol Myers Squibb’s Cobenfy appear set to arrive later this year.
Bristol Myers Squibb is leaning on safety as a key differentiator as it looks to expand its schizophrenia drug Cobenfy into Alzheimer’s disease psychosis.
“There are probably 7 million diagnosed with Alzheimer’s disease,” Adam Lenkowsky, chief commercialization officer, told investors during the pharma’s first quarter earnings call on Thursday. Around 30% to 50% of these patients suffer from psychosis, he said.
“So this presents real significant unmet need where there are no approved treatments today.”
The two big Alzheimer’s disease therapies currently on the market—Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla—are not specifically indicated for the psychosis symptom associated with the neurodgenerative disorder. Meanwhile, the antipsychotic drugs commonly used to manage psychotic episodes come with “significant safety limitations,” according to Lenkowsky.
Many carry boxed warnings for an increased risk of death in elderly patients with dementia—a key Alzheimer’s patient population. Leqembi and Kisunla also have black box warnings for amyloid-related imaging abnormalities that could indicate swelling or bleeding in the brain.
This could be where Cobenfy makes its mark, Lenkowsky told investors. “Safety becomes increasingly important in an elderly population, where Cobenfy . . . doesn’t carry a boxed warning.”
Cobenfy came to BMS in late 2023 when the pharma dropped $14 billion to acquire Karuna Therapeutics. The drug, dubbed KarXT, was still investigational at the time, but won the FDA’s go-ahead for schizophrenia less than a year later in September 2024.
BMS has since continued to develop Cobenfy, but results have been disappointing. In April 2025, the drug failed to significantly improve symptoms in patients with schizophrenia when used with atypical antipsychotics.
In Alzheimer’s disease psychosis, the pharma is running the Phase 3 ADEPT-2 study. Data from this trial were expected by the end of 2025, but the pharma announced in December that it found “irregularities” with how the study was being conducted “at a small number of study sites” and would therefore need to push back the readout.
Company executives did not provide a specific timeline for when the ADEPT-2 results will come, only noting that the data drop will happen later this year.
In Q1, BMS made $11.5 billion, a 3% increase year-on-year and a 6% beat versus the consensus estimate of $10.9 billion. Cobenfy—closely watched as one of BMS’ next-generation growth drivers as it maneuvers past major patent expiries in the coming year—brought in $56 million, narrowly beating consensus estimates by 1%.
Cobenfy had been struggling commercially, with uptake largely underwhelming analysts.
The blockbuster blood thinner Eliquis was once again the pharma’s top-performing product, growing 16% to hit $4.14 billion in revenue. This was followed by the cancer therapy Opdivo, which brought in $2.15 billion despite slipping 5% from the same period in 2025.
Other major growth drivers include the hypertrophic cardiomyopathy drug Camzyos, which surged 97% to make $314 million in Q1, and the lymphoma CAR T therapy Breyanzi, which jumped 56% to earn $411 million.
Looking ahead to the rest of the year, BMS is maintaining its previous financial forecast, with total revenues projected to hit between $46 million and $47.5 million.
