TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2026 Annual Meeting
Rhea-AI Summary
TG Therapeutics (NASDAQ: TGTX) announced presentations of data on BRIUMVI (ublituximab‑xiiy) for relapsing multiple sclerosis at the American Academy of Neurology 2026 annual meeting in Chicago on April 22, 2026.
Presentations cover real‑world outcomes from the Phase 4 ENABLE observational study and dosing/safety updates from the ENHANCE study; posters and links are available on the company Publications page.
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News Market Reaction – TGTX
On the day this news was published, TGTX gained 4.82%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TGTX slipped 1.84% while momentum peers were mixed: CYTK was up 3.86% and RNA was down 3.77%. Broader biotech peers in the watch list also showed both gains and losses, suggesting today’s move reflected stock-specific dynamics rather than a synchronized sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 15 | Phase 3 enrollment | Positive | +0.1% | Completion of enrollment for Phase 3 subcutaneous BRIUMVI non-inferiority trial. |
| Mar 19 | Financing & buyback | Positive | +1.1% | New credit facility, $500M net non-dilutive capital and expanded buyback program. |
| Mar 12 | Peer earnings update | Neutral | -4.0% | Precision BioSciences Q4/FY results and clinical pipeline update, sector-relevant news. |
| Mar 09 | Efficacy data publication | Positive | -0.3% | Published BRIUMVI data showing major relapse and MRI activity reductions vs teriflunomide. |
| Mar 06 | Conference schedule | Neutral | +0.8% | Announcement of AAN 2026 schedule for ENABLE Phase 4 and ENHANCE safety posters. |
Recent BRIUMVI-related data and trial updates have generally seen small price moves, with one notable divergence where strong efficacy data coincided with a slight share decline.
Over the last few months, TG Therapeutics has focused on expanding evidence and lifecycle opportunities for BRIUMVI. On Apr 15, it completed enrollment for a Phase 3 trial of subcutaneous BRIUMVI, with a modest 0.12% move. A Mar 19 financing and expanded buyback drove a 1.07% gain. Earlier in March, strong published efficacy data in highly active MS on Mar 9 saw a slight -0.27% reaction, while the initial AAN 2026 presentation schedule on Mar 6 produced a 0.83% move. Today’s detailed AAN data presentations continue this cadence of BRIUMVI-focused updates.
Regulatory & Risk Context
An effective Form S-3ASR shelf filed on Aug 8, 2025 allows TG Therapeutics to offer common stock, preferred stock, warrants, debt securities, and units from time to time for general corporate purposes. No usage of this shelf has been recorded yet in the provided data.
Market Pulse Summary
This announcement highlights new AAN 2026 data for BRIUMVI in relapsing multiple sclerosis, including real-world evidence from the ENABLE Phase 4 observational study and dosing insights from ENHANCE. These updates build on prior trial and post hoc analyses demonstrating BRIUMVI’s clinical profile and follow recent milestones such as Phase 3 subcutaneous enrollment completion. Investors may track forthcoming detailed results, evolution of dosing strategies, and how these data integrate with TG Therapeutics’ broader development and commercialization plans.
Key Terms
relapsing multiple sclerosis medical
phase 4 medical
observational study medical
dosing regimen medical
AI-generated analysis. Not financial advice.
NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2026 annual meeting in Chicago. Links to each presentation are included below.
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We are excited to present new data at AAN 2026 further supporting the differentiated profile of BRIUMVI for people living with relapsing multiple sclerosis. The results from the ENABLE and ENHANCE studies continue to build on our growing body of evidence demonstrating the real-world effectiveness, safety, and tolerability of BRIUMVI, and provide insights into optimized dosing approaches for IV BRIUMVI, respectively. We look forward to continuing to expand the clinical and real-world data supporting BRIUMVI as an important treatment option in adults with RMS.”
TG PRESENTATIONS:
Poster Presentation Title: Real World Clinical Experience from ENABLE, the First Phase 4 Observational Study for Patients with Relapsing Multiple Sclerosis Initiating Ublituximab
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: Safety and Tolerability of a Modified Ublituximab Dosing Regimen: Updates from the ENHANCE Study
Lead Author: Barry A. Singer, MD - Director, The MS Center for Innovations in Care - Missouri Baptist Medical Center, St. Louis, MO, United States
The above presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications/.
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.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in
Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.
Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.
Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately
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, 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.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward- looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding the ULTIMATE I & II Phase 3 studies, the ULTIMATE KIDS I & II studies, the ENHANCE study, the ENABLE study and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from any studies evaluating BRIUMVI that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236.
