TG Therapeutics to show phase 4 and paediatric trial updates for Briumvi at ACTRIMS 2026

TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting Briumvi (ublituximab-xiiy), to be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 5 – 7, 2026 in San Diego, California.

Abstracts are now available online and can be accessed on the ACTRIMS meeting website at www.forum.actrims.org. Details of the upcoming presentations are outlined below.

TG PRESENTATIONS:

Poster Presentation Title: Real-World Infusion Experience with Ublituximab in ENABLE: the First Phase 4 Observational Study for Patients with Relapsing Multiple Sclerosis Initiating Ublituximab

• Presentation Date/Time: Friday, Feb. 6, 2026, 6:45 – 7:30pm PST
• Session: Poster Session 2
• Abstract Number/Poster Number: 387/P413
• Lead Author: Carrie Hersh, DO, MSc, FAAN – Cleveland Clinic Lou Ruvo Center for Brain Health (CCLRCBH) (MS) & Neuroimmunology Specialist – Assoc. Professor of Neurology at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University

Poster Presentation Title: Study Design of a Phase 2 Ublituximab Dose Confirmation Study in Children and Adolescents with Relapsing Multiple Sclerosis: ULTIMATE KIDS I

• Presentation Date/Time: Thursday, Feb. 5, 2026, 6:45 – 7:30pm PST
• Session: Poster Session 1 (5:45 – 7:30pm PST)
• Abstract Number/Poster Number: 306/P115
• Lead Author: K. Mok, PhD – VP Clinical Development, Global Operations TG Therapeutics

Poster Presentation Title: Study Design of a Phase 3, Randomized, Double-Blind Study of Ublituximab Versus Fingolimod in Children and Adolescents with Relapsing Multiple Sclerosis: ULTIMATE KIDS II

• Presentation Date/Time: Thursday, Feb. 5, 2026, 6:00-6:45pm PST
• Session: Poster Session 1 (5:45 – 7:30pm PST)
• Abstract Number/Poster Number: 307/P116
• Lead Author: K. Mok, PhD – VP Clinical Development, Global Operations TG Therapeutics

OTHER PRESENTATIONS OF BRIUMVI DATA:
Poster Presentation Title: Multi-protein Biomarker Test Results for Participants Treated with Ublituximab from the Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (ENHANCE)

• Presentation Date/Time: Thursday, Feb. 5, 2026, 6:00 – 6:45pm PST
• Session: Poster Session 1 (5:45 – 7:30pm PST)
• Abstract Number/Poster Number: 538/P040
• Lead Author: S. McCurdy – Octave Bioscience, Menlo Park, CA

Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.

ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as Briumvi. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

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 countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.