Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.
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Study Overview: Bristol-Myers Squibb is conducting a study titled ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring. The study aims to assess the safety of ozanimod exposure during pregnancy and its effects on maternal, fetal, and infant outcomes, which is crucial for understanding the implications of this treatment in pregnant women with ulcerative colitis.
Intervention/Treatment: The study involves observing pregnant women with ulcerative colitis who are exposed to ozanimod, a medication intended to manage their condition, and comparing them with those exposed to conventional or advanced therapies.
Study Design: This is an observational cohort study with a prospective time perspective. It involves monitoring participants over a period to gather data on the outcomes of interest without any intervention allocation or masking.
Study Timeline: The study was first submitted on July 12, 2023, and is not yet recruiting. The last update was submitted on June 26, 2025. These dates are important as they indicate the study’s progress and timeline for potential results.
Market Implications: The study’s findings could significantly impact Bristol-Myers Squibb’s stock performance and investor sentiment, especially if ozanimod is proven safe for use during pregnancy, potentially expanding its market. Competitors in the ulcerative colitis treatment space may also be affected as new safety data could shift treatment preferences.
The study is ongoing, with further details available on the ClinicalTrials portal.
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