Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. has launched a new clinical study titled ‘Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry.’ The study aims to assess the risk of major congenital malformations in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) during pregnancy. It also compares these outcomes with those in women exposed to other disease-modifying therapies (DMTs) or none at all, as well as with women without MS.
The study focuses on the drug diroximel fumarate, which is being tested for its safety and effects on pregnancy outcomes in women with MS. The goal is to understand how DRF exposure impacts pregnancy compared to other DMTs or no treatment.
This observational study is designed as a cohort study with a prospective time perspective. It aims to follow participants over a 52-week period to gather data on pregnancy outcomes.
The study officially started on October 27, 2023, with an estimated completion date set for July 31, 2025. These dates are crucial for tracking the study’s progress and evaluating its findings in a timely manner.
The results of this study could significantly influence Biogen’s stock performance, as positive outcomes may enhance investor confidence and market position, especially in comparison to competitors in the MS treatment space.
The study is currently recruiting participants, and further details can be accessed on the ClinicalTrials portal.