TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial

About this update from Tg Therapeutics, Inc.

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. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated: “We are very pleased to share these positive results from our ENHANCE Phase 3 trial. By eliminating the need for a second infusion visit two weeks after treatment initiation, this streamlined dosing regimen has the potential to accelerate time from prescription to treatment and reduce scheduling burdens at busy infusion centers. If this consolidated dosing is approved, BRIUMVI would be the first and only IV anti-CD20 for which therapy can be initiated with a single infusion.” Mr. Weiss continued, “People living with RMS already manage significant complexity in their daily lives, and we believe treatment simplicity matters. These results reflect our broader commitment not only to developing effective therapies, but also to improving the treatment experience for patients and healthcare providers. We look forward to engaging with regulatory authorities regarding these data, with the goal of submitting a supplemental BLA in the second half of 2026.” OVERVIEW OF THE ENHANCE PHASE 3 STUDY AND KEY FINDINGS Design: The Phase 3b ENHANCE trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the pharmacokinetics, safety, and MRI outcomes of a con...

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