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TG Therapeutics Announces Presentation of Data for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

TGTX
  • TG Therapeutics announced the presentation of BRIUMVI (ublituximab-xiiy) data at the ACTRIMS annual forum in San Diego on Feb. 06, 2026.
  • Presentations include real-world infusion experience from the ENABLE Phase 4 observational study & study designs for the Phase 2 ULTIMATE KIDS I & Phase 3 ULTIMATE KIDS II trials in children & adolescents with RMS.
  • The ULTIMATE I & II Phase 3 trials are randomized, double-blind studies comparing BRIUMVI to teriflunomide in 1,094 adult RMS patients across 10 countries.
  • BRIUMVI is a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, indicated for RMS in adults in the U.S. & several other countries.
  • Contraindications for BRIUMVI include active Hepatitis B infection & a history of life-threatening infusion reactions.
  • Infusion reactions occurred in 48% of BRIUMVI-treated patients in trials, with 0.6% being serious & 3 infection-related deaths reported in the overall trial population.
  • Infections occurred in 56% of BRIUMVI-treated patients compared to 54% for teriflunomide, with serious infections at 5% vs 3% respectively.
  • Warnings cover Hepatitis B reactivation, Progressive Multifocal Leukoencephalopathy (PML), reduced vaccine effectiveness, fetal risks, immunoglobulin reduction, & potential liver injury.
  • The most common adverse reactions (incidence ≥10%) were infusion reactions & upper respiratory tract infections.
  • TG Therapeutics offers a BRIUMVI Patient Support program for U.S. patients via www.briumvipatientsupport.com.
  • The press release includes forward-looking statements regarding the ULTIMATE, ENHANCE, & ENABLE studies, noting risks that actual results may differ materially from expectations.