Bristol-Myers Squibb’s New Study on Ozanimod: Implications for Pregnant Women with Ulcerative Colitis

Bristol-Myers Squibb Company ((BMY)) announced an update on their ongoing clinical study.

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 evaluate the safety of ozanimod exposure during pregnancy and its effects on maternal, fetal, and infant outcomes, which is significant for understanding the implications of treating ulcerative colitis (UC) in pregnant women.

Intervention/Treatment: The study focuses on the drug ozanimod, a treatment for ulcerative colitis. It will compare outcomes in pregnant women with UC exposed to ozanimod, conventional therapies, and advanced therapies, providing insights into the safety and efficacy of these treatments during pregnancy.

Study Design: This is an observational cohort study with a prospective time perspective. It will track pregnant women with UC exposed to different therapies, focusing on real-world outcomes without intervention allocation or masking, aiming to gather data on safety and health impacts.

Study Timeline: The study is set to begin on August 25, 2025, with an estimated duration of 21 months. The primary completion and overall study completion dates are yet to be determined. The last update was submitted on June 26, 2025, indicating ongoing preparations for recruitment.

Market Implications: This study could influence Bristol-Myers Squibb’s stock performance by providing critical safety data on ozanimod, potentially affecting its market acceptance and competitive positioning. Positive outcomes may boost investor confidence, while negative results could benefit competitors offering alternative UC treatments.

The study is ongoing, with further details available on the ClinicalTrials portal.