TG Therapeutics' Phase 3 trial shows single-dose BRIUMVI infusion matches current two-dose regimen for MS treatment

TG Therapeutics announced positive Phase 3 ENHANCE trial results demonstrating that a single 600 mg infusion of BRIUMVI for relapsing multiple sclerosis (RMS) provides bioequivalent drug exposure compared to the current two-dose initiation regimen. This new dosing could simplify treatment by eliminating the need for a second infusion two weeks later, potentially speeding up therapy start and easing scheduling at infusion centers. Safety and efficacy were consistent with previous studies, with no new safety concerns. TG Therapeutics plans to submit a supplemental Biologics License Application (BLA) in the second half of 2026 to seek approval for this streamlined dosing.