Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb Company is conducting a Phase IV postmarketing study titled ‘A Lactation Study in Women Receiving Treatment With Ozanimod.’ The study aims to evaluate the concentrations of ozanimod and its major metabolites in the breast milk of lactating women and assess the effects on breastfed infants. This research is significant as it provides insights into the safety and implications of ozanimod use during lactation.
Intervention/Treatment: The intervention involves collecting breast milk, plasma, and blood samples from lactating women and their infants. Although the treatment with ozanimod is not altered, the study is considered interventional due to the diagnostic tests and monitoring procedures involved.
Study Design: The study is interventional with a single-group model and no masking. It focuses on treatment as its primary purpose, aiming to gather data on ozanimod’s presence in breast milk and its potential impact on infants.
Study Timeline: The study began on September 16, 2025, with an estimated start date. The last update was submitted on August 5, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: This study update could influence Bristol-Myers Squibb’s stock performance by providing valuable data on ozanimod’s safety profile, potentially boosting investor confidence. In a competitive pharmaceutical landscape, such insights are crucial for maintaining a competitive edge and reassuring stakeholders about the company’s commitment to patient safety.
The study is ongoing, and further details are available on the ClinicalTrials portal.