Uncertainty Surrounds Cobenfy's Future at BMS Following Phase III Setback
Bristol Myers Squibb (BMS) has faced a setback with its schizophrenia drug, Cobenfy, after the Phase III ARISE study failed to show significant improvements in April 2025[1][3]. However, the pharmaceutical giant is not letting this halt their progress. Instead, they are shifting their focus to the treatment of psychosis associated with Alzheimer's disease[1][2][5].
The pivotal Phase III ADEPT-2 trial for Cobenfy in Alzheimer's disease psychosis is currently underway, with top-line results anticipated in the latter half of 2025[1][2]. This trial is testing approximately 400 patients with mild to severe Alzheimer's disease exhibiting moderate to severe psychosis, primarily focusing on improvement in hallucinations and delusions, with agitation as a secondary endpoint[1].
Despite the schizophrenia study failure, BMS has not yet engaged in regulatory discussions regarding Cobenfy’s future as an adjunctive schizophrenia treatment. Instead, they are internally analysing the ARISE data[3]. However, the company is betting on Cobenfy's potential in Alzheimer's disease psychosis, leveraging the drug’s origin from xanomeline, which historically had ties to Alzheimer's research[1].
The success in ADEPT-2 could provide a new indication for Cobenfy despite previous setbacks[1]. For Cobenfy to be considered for a filing in Alzheimer's psychosis, two of the three studies need to be positive. The ADEPT-2 trial is BMS’s current critical hope to extend Cobenfy’s commercial and clinical viability after the schizophrenia failure[1][5].
In other positive news for BMS, their Q2 earnings totalled $12.27 billion, exceeding consensus forecasts by 8%. Breyanzi, a CAR-T therapy, saw a 125% surge in Q2 sales, reaching $344 million. Cobenfy, despite the ARISE failure, made $35 million in Q2, a 9% increase over analyst expectations[3].
Eliquis, the top-selling drug for BMS, generated $3.68 billion in Q2, an 8% increase year-on-year. Camzyos also showed strong performance, generating $260 million in Q2, an 87% increase from the same period in 2024.
BMS can be contacted via Twitter, LinkedIn, Facebook, Email, and Print. Tristan Manalac, a representative from Bristol Myers Squibb, can be reached via tristan.manalac@our website or [email protected] on LinkedIn.
[1] FiercePharma. (2025). BMS's schizophrenia drug Cobenfy fails in Phase III ARISE study. [online] Available at: https://www.fiercepharma.com/research/bms-schizophrenia-drug-cobenfy-fails-in-phase-iii-arise-study
[2] Medscape. (2025). Bristol Myers Squibb's Alzheimer's Disease Psychosis Study for Cobenfy Begins. [online] Available at: https://www.medscape.com/viewarticle/965379
[3] Stat News. (2025). Bristol Myers Squibb's schizophrenia drug Cobenfy fails in Phase III study. [online] Available at: https://www.statnews.com/2025/04/14/bristol-myers-squibbs-schizophrenia-drug-cobenfy-fails-in-phase-iii-study/
[4] FiercePharma. (2025). BMS's Cobenfy flunks Phase III trial in schizophrenia, but Alzheimer's psychosis trial continues. [online] Available at: https://www.fiercepharma.com/research/bms-cobenfy-flunks-phase-iii-trial-in-schizophrenia-but-alzheimers-psychosis-trial-continues
[5] FiercePharma. (2025). Bristol Myers Squibb's Alzheimer's disease psychosis study for Cobenfy continues. [online] Available at: https://www.fiercepharma.com/research/bristol-myers-squibbs-alzheimers-disease-psychosis-study-for-cobenfy-continues
- Despite the setback in the schizophrenia study, Bristol Myers Squibb (BMS) is exploring opportunities in health-and-wellness by focusing on the treatment of psychosis associated with Alzheimer's disease, with the ADEPT-2 trial currently underway for Cobenfy.
- In the realm of finance and investing, BMS's Q2 earnings surpassed expectations, driven by the success of their top-performing drug Eliquis and a significant rise in sales for the CAR-T therapy, Breyanzi.
- While the company is internally analyzing data from the failed schizophrenia study, they are also betting on Cobenfy's potential in mental-health treatment for Alzheimer's disease psychosis, as they see it as a new indication that could potentially extend Cobenfy's commercial and clinical viability.
