TG Therapeutics ((TGTX)) announced an update on their ongoing clinical study.
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Study Overview: TG Therapeutics is conducting a post-marketing study titled ‘A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk’ (PROVIDE). The study aims to assess the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who are receiving the drug for the treatment of relapsing forms of multiple sclerosis (RMS). This research is significant as it addresses safety concerns for breastfeeding mothers undergoing treatment.
Intervention/Treatment: The study involves the collection of breast milk from participants with RMS who are therapeutically receiving BRIUMVI™. No additional interventions are applied, as the focus is on measuring the drug’s concentration in milk samples.
Study Design: This is an observational cohort study with a prospective time perspective. The primary purpose is to gather data on the concentration of BRIUMVI™ in breast milk, providing valuable insights into its safety profile for breastfeeding mothers.
Study Timeline: The study began on November 16, 2023, with the latest update 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: This study update could influence TG Therapeutics’ stock performance by potentially enhancing investor confidence in the safety and marketability of BRIUMVI™. As the study addresses a critical safety concern, positive outcomes may strengthen the company’s position in the competitive multiple sclerosis treatment market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.