TG Therapeutics Inc. (TGTX), a commercial-stage biotechnology company, announced on Wednesday the completion of enrollment in its Phase 3 trial evaluating subcutaneous BRIUMVI for the treatment of relapsing forms of multiple sclerosis.
Relapsing forms of multiple sclerosis (RMS) is a chronic, autoimmune, demyelinating disease of the central nervous system (CNS). It is estimated that over 1 million people live with MS in the U.S., and more than 2.3 million worldwide.
BRIUMVI (ublituximab-xiiy), a monoclonal antibody targeting a unique epitope on CD20-expressing B-cells, is approved by the U.S. FDA as a one-hour intravenous (IV) infusion for adults with RMS.
The Phase 3 trial is a non-inferiority, randomized, open-label, multicenter study, with three arms, evaluating two dosing regimens of subcutaneous BRIUMVI- every 8 weeks and every 12 weeks- compared to the approved IV schedule. The primary endpoint will assess non-inferior pharmacokinetic exposure (AUC at week 24) between subcutaneous and IV formulations.
Chairman and CEO Michael S. Weiss said, "We believe subcutaneous BRIUMVI has the potential to significantly broaden our reach by offering patients greater flexibility, including a self-administered at-home option, and we look forward to sharing topline data from this trial around year end 2026 or early 2027".
TGTX has traded between $25.28 and $46.48 over the past year. The stock closed Wednesday at $34.60, up 0.12%. In the overnight market, shares are trading at $34.04, down 1.62%.
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