Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc. is conducting a study titled Pregnancy Outcomes in Women Exposed to Diroximel Fumarate, aiming to assess the safety of Diroximel Fumarate (VUMERITY®) in pregnant women with multiple sclerosis (MS) and the health of their babies. The study’s primary goal is to gather data on major congenital malformations and other pregnancy outcomes in three groups: those exposed to Diroximel Fumarate, those on other MS drugs, and those on no MS drugs during pregnancy.
The intervention being tested is Diroximel Fumarate, a drug used to treat relapsing forms of MS. It is being compared to other disease-modifying therapies (DMTs) and no treatment to evaluate its safety during pregnancy.
This observational study follows a cohort model with a prospective time perspective. It involves collecting health information from participants without altering their medical care. The primary focus is on understanding the birth outcomes and health of babies born to mothers with MS.
The study began on January 9, 2023, with an estimated completion date of April 30, 2031. The last update was submitted on October 15, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates.
Market implications of this study could be significant for Biogen, as positive results may enhance investor confidence and potentially boost stock performance. The study’s findings could also influence the competitive landscape in the MS treatment market, particularly among companies offering alternative DMTs.
The study is ongoing, with further details available on the ClinicalTrials portal.