TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2025 Annual Meeting

Company Overview - TG Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases, including relapsing forms of multiple sclerosis (RMS) [24][25] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [24][25] Product Information - BRIUMVI is a novel monoclonal antibody targeting CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through a process called glycoengineering [5][6] - The drug has shown a favorable tolerability profile in real-world settings, with a lower rate of infusion-related reactions compared to Phase 3 trials [2][3] Clinical Data - The retrospective ENAMOR survey included data from approximately 400 individuals treated with BRIUMVI across 21 MS centers, indicating a favorable tolerability profile [2] - The ENABLE Phase 4 observational study will enroll approximately 500 patients across 100 MS centers in the U.S. to further evaluate the efficacy and tolerability of BRIUMVI [2] - In the ULTIMATE I & II Phase 3 trials, a total of 1,094 patients were enrolled across 10 countries, demonstrating the drug's effectiveness over a 96-week treatment period [4] Safety and Efficacy - After five years of BRIUMVI treatment, the frequency of serious infections remained consistent with Phase 3 trials, with no observed cases of Progressive Multifocal Leukoencephalopathy (PML) [2] - The overall rate of infections in BRIUMVI-treated patients was 56%, compared to 54% in those treated with teriflunomide, with serious infections occurring at a rate of 5% [9] Market Context - Relapsing multiple sclerosis is a chronic demyelinating disease affecting nearly 1 million people in the U.S., with approximately 85% initially diagnosed with relapsing-remitting multiple sclerosis [23] - The global prevalence of multiple sclerosis is over 2.3 million, indicating a significant market opportunity for effective treatments like BRIUMVI [23]