TG Therapeutics ((TGTX)) announced an update on their ongoing clinical study.
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Study Overview: TG Therapeutics is conducting a study titled BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®. The study aims to evaluate the prevalence of major congenital malformations (MCM) in pregnant participants with Multiple Sclerosis (MS) who are exposed to BRIUMVI® compared to those who are not. This research is significant as it seeks to provide crucial insights into the safety of BRIUMVI® during pregnancy.
Intervention/Treatment: The study involves two cohorts: one where pregnant participants with MS are exposed to BRIUMVI® and another where they are not. BRIUMVI® is a treatment for MS, and the study does not involve any additional interventions.
Study Design: This is an observational, prospective cohort study. Participants are grouped based on their exposure to BRIUMVI®, with no intervention being applied. The primary purpose is to observe and compare outcomes between the two groups.
Study Timeline: The study began on May 23, 2024, and the latest update was submitted on September 30, 2025. These dates are crucial as they indicate the study’s progress and the timeliness of the data being collected.
Market Implications: The ongoing study could impact TG Therapeutics’ stock performance and investor sentiment, particularly if the results show favorable safety outcomes for BRIUMVI® during pregnancy. This could position TG Therapeutics favorably against competitors in the MS treatment market, potentially influencing market dynamics.
The study is currently recruiting, with further details available on the ClinicalTrials portal.