Bristol-Myers Squibb (BMS) Stock Drops 3.09% After ARISE III Trial Disappointment
1min read On April 23, 2025, Bristol-Myers Squibb's stock dropped 3.09% in pre-market trading.
Bristol-Myers Squibb (BMS) recently announced the topline results of its ARISE III phase trial for Cobenfy (xanomeline and trospium chloride). The trial aimed to evaluate Cobenfy as an adjunctive treatment for adult patients with schizophrenia. However, the results showed that Cobenfy did not statistically significantly outperform the placebo. Despite this, preliminary analysis indicated that Cobenfy, when combined with atypical antipsychotic drugs, showed a trend of improving schizophrenia symptoms in certain patients.
In the ARISE III trial, Cobenfy as an adjunctive treatment showed a reduction of only 2.0 points in the Positive and Negative Syndrome Scale (PANSS) total score at week 6 compared to the placebo, which was not statistically significant (p=0.11). However, a post-hoc subgroup analysis revealed significant differences in responses between patients receiving risperidone as background treatment and those receiving other background antipsychotic drugs (non-risperidone). In the non-risperidone subgroup, the PANSS total score of the Cobenfy treatment group was significantly lower than that of the placebo group, with a p-value of 0.03.
BMS plans to further analyze the data and discuss potential next steps with the medical community and regulatory authorities. The company emphasizes that developing effective adjunctive treatments is challenging due to the variability in patient responses and the difficulty in proving additional efficacy on top of existing atypical antipsychotic drugs. The clinical development program for Cobenfy continues, with ongoing trials in other neuropsychiatric diseases such as Alzheimer's disease, autism spectrum disorder, and bipolar affective disorder. Additionally, the ARISE trial includes a 52-week open-label extension study to further explore the long-term safety and efficacy of Cobenfy as an adjunctive treatment.
