BMS's Cobenfy Faces Uncertain Future Amid Mixed Clinical Results

Bristol Myers Squibb's (BMS) schizophrenia drug Cobenfy is facing an uncertain future following disappointing results in a Phase III clinical trial. The pharmaceutical giant is now reassessing the drug's potential while awaiting results from ongoing studies in Alzheimer's disease psychosis.

ARISE Study Setback

The Phase III ARISE study, which tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia, failed to demonstrate significant symptom improvement earlier this year. This setback has led to questions about the drug's viability in its intended indication.

During BMS's second quarter earnings call, Chief Medical Officer Samit Hirawat revealed that the company has not yet engaged in discussions with regulatory authorities regarding Cobenfy's future. BMS is still analyzing the ARISE study data and plans to share its findings at a later date.

Alzheimer's Disease Psychosis Trials Ongoing

Despite the setback in schizophrenia, BMS is continuing to pursue Cobenfy's potential in Alzheimer's disease psychosis. The company is currently conducting three Phase III studies:

1. ADEPT-2: A 400-patient trial comparing Cobenfy against placebo, with results expected later this year.
2. ADAPT-1 and ADAPT-4: Two additional studies scheduled to read out next year.

Hirawat emphasized that positive results from at least two of these three studies would be necessary for BMS to engage with regulatory authorities for a potential filing.

Financial Performance and Future Outlook

Despite the uncertainty surrounding Cobenfy, BMS reported strong financial performance in Q2 2025. The company's revenue reached $12.27 billion, surpassing consensus forecasts by 8%. Key products contributing to this success include:

• Eliquis: $3.68 billion (8% year-on-year increase)
• Opdivo: $2.56 billion (7% year-on-year increase)
• Breyanzi: $344 million (125% year-on-year increase)
• Camzyos: $260 million (87% year-on-year increase)

Cobenfy itself generated $35 million in sales, exceeding analyst expectations by 9%. This performance, along with strong growth in other products, has led BMS to raise its full-year 2025 revenue guidance to $46.5-47.5 billion, up from the previous forecast of $45.8-46.8 billion.

As BMS continues to evaluate Cobenfy's potential, the pharmaceutical industry will be closely watching the outcomes of the ongoing Alzheimer's disease psychosis trials, which could significantly impact the drug's future and BMS's portfolio strategy.