New Ublituximab Data Highlight Rapid Patient Gains and a Path Toward Single-Day Treatment Initiation

At the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, new clinical data are spotlighting a shift toward patient-centered outcomes and streamlined treatment regimens for relapsing forms of multiple sclerosis (MS). TG Therapeutics, the developer of the intravenous therapy ublituximab-xiiy (Briumvi), presented a series of findings that suggest the treatment not only provides robust disease control but also offers rapid improvements in the daily lives of patients.^1-3

A Differentiated Approach to CD20 Therapy

Ublituximab is a novel monoclonal antibody designed to target a unique epitope on CD20-expressing B-cells, which play a central role in the autoimmune response of MS. The therapy is glycoengineered, a process that removes specific sugar molecules to enhance its ability to deplete B-cells even at low doses. Although approved for adults with MS, including relapsing-remitting and active secondary progressive disease, the focus at CMSC has shifted from its biological mechanism to its real-world impact.^1-3

The ENABLE Study: Patients Report Rapid Gains

The centerpiece of the presentations was an oral session presented by Carrie Hersh, DO, highlighting results from the phase 4 ENABLE study. This ongoing observational trial is designed to provide real-world evidence that complements the data from the earlier ULTIMATE phase 3 clinical program.¹

The ENABLE data revealed that patients treated with ublituximab experienced significant and durable improvements in patient-reported outcomes (PROs). Using standardized measures like the Treatment Satisfaction Questionnaire for Medication (TSQM) and the MS Impact Scale (MSIS-29), researchers found that patients reported benefits in treatment satisfaction, as well as physical and psychological well-being, as early as day 15. These gains were sustained through 48 weeks of treatment.¹

Furthermore, the ENABLE study highlights a more diverse patient population than previous pivotal trials. The average age of participants is 43 years, and notably, 19.5% of the participants identify as Black or African American—a significant increase from the 1.5% representation in the ULTIMATE I and II trials. For those transitioning to ublituximab from other anti-CD20 therapies, the results were equally compelling: 99.4% of these patients remained relapse-free, with an exceptionally low annualized relapse rate of 0.011.¹

ENHANCE: Simplifying the 1-Hour Infusion

Although ublituximab is already known for its 1-hour maintenance infusions, topline results from the phase 3 ENHANCE trial were also presented at CMSC, which could further simplify the treatment’s initiation. Currently, the approved regimen requires a 150 mg infusion on day 1 followed by a 450 mg infusion on day 15.²

The ENHANCE study met its primary end point, demonstrating that a consolidated single 600 mg infusion on day 1 is bioequivalent to the split-dose initiation. This “1 and done” approach aims to reduce the scheduling burden for patients and busy infusion centers. According to Michael S. Weiss, CEO of TG Therapeutics, if this consolidated dosing is approved, it would make ublituximab the first and only intravenous anti-CD20 therapy that can be initiated with a single visit.²

Safety and Future Outlook

Across all presentations, the safety profile remained consistent with previous findings. The most common adverse reactions continue to be infusion-related reactions (IRRs) and upper respiratory tract infections. The ENHANCE trial reported lower rates of IRRs than the original approval studies, with no grade 3 or higher reactions observed in either treatment arm.^1,2

With these new findings in hand, TG Therapeutics plans to submit a supplemental Biologics License Application for the consolidated dosing regimen in the second half of 2026. For the nearly 1 million people living with MS in the US, these advancements represent a continuing trend toward treatments that prioritize not just efficacy, but also convenience and quality of life.

REFERENCE
1. Hersh CM. Ublituximab significantly improves patient-reported outcomes: results from the phase 4 observational study ENABLE. Presented at: Consortium of Multiple Sclerosis Centers (CMSC) 2026 Annual Meeting. May 28, 2026. Charlotte, NC.

2. TG Therapeutics announces positive topline results from phase 3 ENHANCE trial. News release. TG Therapeutics. May 27, 2026. Accessed May 28, 2026. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-positive-topline-results-phase-3

3. TG Therapeutics announces data presentations for Briumvi at the 2026 Consortium of Multiple Sclerosis Centers Annual Meeting. News release. TG Therapeutics. May 26, 2026. Accessed May 28, 2026. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-data-presentations-briumvir-2026