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Does Cobenfy Have the Potential to Become a Top Drug for BMY?
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Key Takeaways
BMY's schizophrenia drug Cobenfy generated $155M in 2025 with strong uptake post-2024 FDA approval.
Cobenfy uptake outpaced peers, supported by expanded access and adoption across care settings.
BMY advances Cobenfy with phase III studies in Alzheimer's, bipolar disorder, and autism indications.
Bristol Myers’ (BMY - Free Report) schizophrenia drug Cobenfy delivered a sound performance in 2025.
Cobenfy (xanomeline and trospium chloride), formerly KarXT, is an oral medication. It represents the first new pharmacological approach to treat schizophrenia in decades. The FDA approved the drug in September 2024.
The drug’s uptake has been encouraging, with sales reaching $155 million in 2025, driven by expanded access and deeper adoption across community and hospital settings.
According to BMY, Cobenfy’s uptake has outpaced all comparable schizophrenia treatments and relevant analogs in its first year on the market, with continued steady growth expected through 2026.
The uptake of Cobenfy for schizophrenia boosts BMY’s portfolio and validates the acquisition of Karuna Therapeutics.
Bristol Myers recently reported phase II data showing that adults with schizophrenia remained stable after switching to Cobenfy monotherapy over eight weeks, with no new safety concerns.
The study (n=105) found low discontinuation rates (~14–15%), no dropouts due to lack of efficacy, and modest improvements in symptom and functioning scores, regardless of whether patients transitioned over two or four weeks. Results were presented at the Schizophrenia International Research Society Annual Congress 2026.
The drug is anticipated to become a meaningful growth driver for BMY’s top line as the company pursues label expansions across new indications.
BMY has several ongoing phase III studies for Cobenfy in Alzheimer's disease patients. These include studies in Alzheimer's disease psychosis (data expected in 2026), agitation and cognition impairment. The drug is also being evaluated in a Phase III study for bipolar I disorder and pediatric irritability associated with autism.
We note that BMY is banking on newer drugs like Cobenfy and Qvantig to stabilize its revenue base as its legacy drugs face generic competition.
Competition for BMY’s Cobenfy
Developing treatments for diseases like schizophrenia is a complex affair.
AbbVie (ABBV - Free Report) was evaluating emraclidine for schizophrenia. The candidate was added to ABBV’s pipeline through the Cerevel acquisition. In November 2024, AbbVie announced that its two phase II EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale total score compared to the placebo group at week six. ABBV is currently evaluating emraclidine for Alzheimer's disease psychosis.
Reviva Pharmaceuticals Holdings, Inc. is evaluating brilaroxazine in patients with schizophrenia.
In December 2025, RVPH provided a regulatory update after a pre-NDA meeting with the FDA on brilaroxazine. In written feedback, the regulatory body advised Reviva to conduct a second phase III study in schizophrenia to further support efficacy and broaden the safety database.
RVPH plans to initiate a second registrational phase III study (RECOVER-2) on brilaroxazine for schizophrenia in mid-2026. Trial-related activities for RECOVER-2 are expected to begin in the current quarter, with patient enrollment slated to start in the third quarter in the United States.
BMY’s Price Performance, Valuation and Estimates
Shares of Bristol Myers have gained 9.7% year to date against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, the stock currently trades at 9.51x forward earnings, higher than its mean of 8.52x but lower than the large-cap pharma industry’s 17.09x.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.26 from $6.10 in the past 60 days, while that for 2027 has increased to $6.09 from $5.92.
View the Zacks #1 Rank List
Image: Shutterstock
Does Cobenfy Have the Potential to Become a Top Drug for BMY?
Key Takeaways
Bristol Myers’ (BMY - Free Report) schizophrenia drug Cobenfy delivered a sound performance in 2025.
Cobenfy (xanomeline and trospium chloride), formerly KarXT, is an oral medication. It represents the first new pharmacological approach to treat schizophrenia in decades. The FDA approved the drug in September 2024.
The drug’s uptake has been encouraging, with sales reaching $155 million in 2025, driven by expanded access and deeper adoption across community and hospital settings.
According to BMY, Cobenfy’s uptake has outpaced all comparable schizophrenia treatments and relevant analogs in its first year on the market, with continued steady growth expected through 2026.
The uptake of Cobenfy for schizophrenia boosts BMY’s portfolio and validates the acquisition of Karuna Therapeutics.
Bristol Myers recently reported phase II data showing that adults with schizophrenia remained stable after switching to Cobenfy monotherapy over eight weeks, with no new safety concerns.
The study (n=105) found low discontinuation rates (~14–15%), no dropouts due to lack of efficacy, and modest improvements in symptom and functioning scores, regardless of whether patients transitioned over two or four weeks. Results were presented at the Schizophrenia International Research Society Annual Congress 2026.
The drug is anticipated to become a meaningful growth driver for BMY’s top line as the company pursues label expansions across new indications.
BMY has several ongoing phase III studies for Cobenfy in Alzheimer's disease patients. These include studies in Alzheimer's disease psychosis (data expected in 2026), agitation and cognition impairment. The drug is also being evaluated in a Phase III study for bipolar I disorder and pediatric irritability associated with autism.
We note that BMY is banking on newer drugs like Cobenfy and Qvantig to stabilize its revenue base as its legacy drugs face generic competition.
Competition for BMY’s Cobenfy
Developing treatments for diseases like schizophrenia is a complex affair.
AbbVie (ABBV - Free Report) was evaluating emraclidine for schizophrenia. The candidate was added to ABBV’s pipeline through the Cerevel acquisition. In November 2024, AbbVie announced that its two phase II EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale total score compared to the placebo group at week six.
ABBV is currently evaluating emraclidine for Alzheimer's disease psychosis.
Reviva Pharmaceuticals Holdings, Inc. is evaluating brilaroxazine in patients with schizophrenia.
In December 2025, RVPH provided a regulatory update after a pre-NDA meeting with the FDA on brilaroxazine. In written feedback, the regulatory body advised Reviva to conduct a second phase III study in schizophrenia to further support efficacy and broaden the safety database.
RVPH plans to initiate a second registrational phase III study (RECOVER-2) on brilaroxazine for schizophrenia in mid-2026. Trial-related activities for RECOVER-2 are expected to begin in the current quarter, with patient enrollment slated to start in the third quarter in the United States.
BMY’s Price Performance, Valuation and Estimates
Shares of Bristol Myers have gained 9.7% year to date against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, the stock currently trades at 9.51x forward earnings, higher than its mean of 8.52x but lower than the large-cap pharma industry’s 17.09x.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.26 from $6.10 in the past 60 days, while that for 2027 has increased to $6.09 from $5.92.
Image Source: Zacks Investment Research
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.