TG Therapeutics, Inc. (TGTX) on Wednesday reported positive topline results from its Phase 3 ENHANCE study evaluating a single-infusion initiation regimen for BRIUMVI in adults with relapsing forms of multiple sclerosis.
The study achieved its primary endpoint, showing bioequivalent drug exposure between the currently approved dosing schedule of 150 mg on Day 1 and 450 mg on Day 15 and a new consolidated regimen consisting of a single 600 mg infusion on Day 1. The revised approach would remove the need for a second infusion on Day 15.
BRIUMVI is approved in the U.S. for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The therapy is also approved in several international markets for adults with active RMS.
The company said it plans to submit a supplemental Biologics License Application to the U.S. FDA in the second half of 2026.
TGTX stock gained nearly 2% in pre-market trading after closing at $39.73 on Tuesday.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.