Core Insights - TG Therapeutics presented data on BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting [1][2] - The company is optimistic about the ongoing data presentations throughout the year [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S., Europe, and the UK [23] - The company has a pipeline of investigational medicines in addition to BRIUMVI [23] Product Information - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to deplete B-cells efficiently at low doses through glycoengineering [4] - It is indicated for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [5] Clinical Trials - The ULTIMATE I & II trials involved 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - The trials required patients to have experienced at least one relapse in the previous year or two relapses in the previous two years, with specific EDSS score criteria [3] Safety and Efficacy Data - Presentations at the CMSC included findings on the safety and tolerability of BRIUMVI, with a focus on infusion reactions and immunoglobulin levels [2][6] - The incidence of infusion reactions in BRIUMVI-treated patients was reported at 48%, with serious reactions occurring in 0.6% of patients [6][8] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [8] Market Context - Relapsing multiple sclerosis affects nearly 1 million people in the U.S., with 85% initially diagnosed with relapsing-remitting forms [22] - The global prevalence of MS is over 2.3 million [22]
TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting