We are pleased to share that Phase 3 ENHANCE trial met its primary endpoint, key findings are highlighted below:
- The trial met its primary endpoint, demonstrating bioequivalence between the currently approved two-infusion initiation regimen and a new single 600 mg Day 1 infusion regimen.
- Additionally, secondary endpoints, including safety, B-cell depletion, and MRI outcomes, were consistent with prior BRIUMVI® clinical studies, with comparable infusion-related reactions between treatment arms.
If this consolidated dosing is approved, BRIUMVI® would be the first and only IV anti-CD20 in RMS with a single-infusion treatment initiation. Full results are expected to be presented at an upcoming medical meeting.
See below the announcement released on 27/05/2026 by our partner, TG Therapeutics. The full press release is attached.
TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial
May 27, 2026
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 consolidated first infusion regimen of BRIUMVI.
The primary endpoint of the study is to demonstrate bioequivalent overall drug exposure between a single 600 mg Day 1 infusion of BRIUMVI and the currently approved dosing regimen of 150 mg on Day 1 followed by 450 mg on Day 15. Overall drug exposure was measured by area under the serum concentration—time curve from baseline through Week 16 (AUC 0-Wk16). AUC values within each treatment arm are summarized using geometric means and then compared between treatment arms using a ratio of those geometric means (GMR).
Participants were randomized into one of two treatment arms:
- the approved BRIUMVI initiation regimen of 150 mg on Day 1 and 450 mg on Day 15; or
- a new consolidated BRIUMVI initiation regimen of a single 600 mg infusion on Day 1 only and a placebo infusion on Day 15
All subsequent maintenance dosing in both treatment arms followed the currently approved BRIUMVI prescribing information. With both arms receiving the same cumulative dose of 600 mg through Day 15, the study was designed to ensure that comparable drug exposure was achieved across both treatment arms. Secondary endpoints included safety, pharmacodynamics, and efficacy.
Key Findings:
- The trial met its primary endpoint, demonstrating bioequivalence between the new single Day 1 BRIUMVI infusion regimen and the currently approved initiation regimen administered on Days 1 and 15. Total drug exposure over 16 weeks (AUC 0-Wk16) was comparable between treatment arms, with a geometric mean ratio (GMR) of approximately 1.0 and a 90% confidence interval within the protocol-defined bioequivalence range of 0.80 to 1.25.
- Secondary endpoints, including safety, B-cell depletion, and MRI outcomes, were consistent with prior BRIUMVI clinical studies and comparable between treatment arms through the primary assessment period with no new safety signals observed. Infusion-related reactions in both arms were lower than previously reported in the ULTIMATE I and II approval studies for BRIUMVI, with no Grade 3 or higher infusion reactions occurring in either arm. In addition, infusion-related reactions were statistically indistinguishable between treatment arms in this study with fewer infusion reactions observed in the consolidated single-infusion treatment arm.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several foreign nations for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here Briumvi | European MedicinesAgency (europa.eu).
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc