Bristol Myers SquibbBMY
ImmunologyOncologyPsychiatry120 cited findings · profile updated 2026-08-26
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About Bristol Myers Squibb
Bristol Myers Squibb (BMY) demonstrates a therapeutic focus in oncology, immunology, and psychiatry, as evidenced by its regulatory submissions. In oncology, the company's drug SPRYCEL is associated with various adverse events in newly diagnosed chronic phase CML, including fluid retention (38% All Grades) and pleural effusion (28% All Grades). For ZEPOSIA, an immunology drug, the overall rate of infections in MS Study 1 and Study 2 was 35%. In psychiatry, Cobenfy (xanomeline and trospium chloride) received approval for the treatment of schizophrenia in adults, with statistically significant superiority to placebo on the primary efficacy endpoint of change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 5.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Approval Date | May 27, 2021 | BRISTOL — Zeposia FDA Review (NDA/BLA 209899, 2023), p.1 |
| Overall rate of infections | 35 % (ZEPOSIA) vs 34 % (IFN beta-1a) | BRISTOL — Zeposia FDA Review (NDA/BLA 209899, 2023), p.14 |
| Fluid retention (All Grades) | 38 % (newly diagnosed chronic phase CML) | Bristol-Myers Squibb Company — Sprycel FDA Review (NDA/BLA 021986, 202, p.18 |
| Pleural effusion (All Grades) | 28 % (newly diagnosed chronic phase CML) | Bristol-Myers Squibb Company — Sprycel FDA Review (NDA/BLA 021986, 202, p.18 |
| Approved indication | Treatment of schizophrenia in adults | Bristol-Myers Squibb Company — Cobenfy FDA Review (NDA216158, ORIG 1, , p.2 |
| Superiority to placebo on primary efficacy endpoint | statistically significant (Cobenfy (xanomeline tartrate and trospium chloride)) | Bristol-Myers Squibb Company — Cobenfy FDA Review (NDA216158, ORIG 1, , p.31 |
Key projects
- Zeposia (Ozanimod Hydrochloride) (treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Moderately to severe active ulcerative colitis (UC) in adults.)
Zeposia (Ozanimod Hydrochloride) received approval on May 27, 2021.
- Cobenfy (xanomeline and trospium chloride) (Schizophrenia)
Cobenfy (xanomeline tartrate and trospium chloride) demonstrated statistically significant superiority to placebo on the primary efficacy endpoint of change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 5.
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