TG Therapeutics(US:TGTX) Newsfilter·2024-05-28 11:30Core Insights - TG Therapeutics, Inc. announced upcoming presentations for post-marketing studies of BRIUMVI® (ublituximab-xiiy) at the 2024 Consortium of Multiple Sclerosis Centers annual meeting [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for relapsing forms of multiple sclerosis (RMS) [25] - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [4] Clinical Trials - The ULTIMATE I & II trials are Phase 3 studies involving 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - Patients in these trials had experienced at least one relapse in the previous year or had specific MRI findings, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [3] Product Information - BRIUMVI is indicated for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [5] - The drug is administered as an IV infusion, with specific dosing schedules outlined for both BRIUMVI and the comparator drug [3] Safety and Efficacy - Infusion reactions occurred in 48% of BRIUMVI-treated patients, with serious reactions in 0.6% [8] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [10] - No cases of Progressive Multifocal Leukoencephalopathy (PML) were reported in BRIUMVI-treated patients, although monitoring for symptoms is advised [13] Market Context - Relapsing multiple sclerosis affects nearly 1 million people in the U.S., with 85% initially diagnosed with relapsing-remitting forms [24] - The global prevalence of MS is over 2.3 million, indicating a significant market for effective treatments like BRIUMVI [24]