Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc. is currently recruiting participants for a 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 pregnancy outcomes with women exposed to other disease-modifying therapies (DMTs) or unexposed to any DMTs.
The intervention being tested is Diroximel Fumarate, a drug intended to manage MS symptoms. The study also considers other DMTs such as Avonex and Tysabri for comparative analysis.
This observational study follows a cohort model with a prospective time perspective, focusing on understanding pregnancy outcomes in women with MS. The primary purpose is to gather data on the safety of DRF during pregnancy.
The study began on December 12, 2022, with an estimated primary completion date yet to be determined. The last update was submitted on July 31, 2025, indicating ongoing recruitment and data collection.
For investors, the study’s outcomes could influence Biogen’s stock performance, especially if DRF is found to be safe during pregnancy, potentially boosting market confidence. Competitors in the MS treatment market may also be affected by these findings.
The study is ongoing, with further details available on the ClinicalTrials portal.