TG Therapeutics Says Topline Results From Phase 3 ENHANCE Trial Meets Primary Endpoint, Demonstrating Bioequivalent Drug Exposure Between Currently Approved BRIUMVI Day 1 And Day 15 Initiation Dosing And New Single Infusion On Day 1 Only

TG Therapeutics, Inc.

TG Therapeutics, Inc.

TGTX

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Phase 3 trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI Day 1 and Day 15 initiation dosing and a new single infusion on Day 1 only

Safety and tolerability of the consolidated first infusion were consistent with the established BRIUMVI safety profile

Supplemental BLA filing targeted 2H-2026

NEW YORK, May 27, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved initiation dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Topline outcomes from the ENHANCE Phase 3 study are highlighted below, and full results are expected to be presented at an upcoming medical meeting.

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