Key Takeaways
- Bristol’s Cobenfy did not achieve statistical significance on the primary endpoint in the Phase III ARISE clinical trial testing the drug as an add-on to antipsychotic medicines in schizophrenia.
- Approved in the US as a monotherapy in September 2024, doctors already prescribe Cobenfy in the adjunctive setting for some patients, given the need for additive medicines and long-term practice of combination therapy despite no drug approvals for adjunctive use in schizophrenia.
- Analysts expect some impact on sales, but most say adjunctive use is likely to continue. Even so, investor confidence in BMS took a hit after the company’s other recent setback for Camzyos.
Bristol Myers Squibb made a $14bn gamble when it agreed to buy Karuna Therapeutics in late 2023 for its drug that was pending US Food and Drug Administration approval at the time of the acquisition
BMS announced after the stock market closed on 22 April that its oral M1/M4 muscarinic receptor agonist/muscarinic receptor antagonist did not achieve statistical significance as an add-on therapy on the primary endpoint of Positive and Negative Syndrome Scale (PANSS) total score in the Phase III ARISE clinical trial
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