TG Therapeutics 在 MSToronto2026 公布 BRIUMVI 七年期等阳性数据，Azer-cel PPMS 一期数据将于 10 月 23 日才正式披露

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TG Therapeutics Highlights New Clinical Data Across Multiple Sclerosis Portfolio at MSToronto2026
Oct 21, 2026
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Seven-year BRIUMVI data demonstrate sustained disease control, with approximately 88% of participants remaining free from confirmed disability progression after 7 years of continuous treatment
Phase 1 subcutaneous BRIUMVI bioavailability data support quarterly dosing schedule being evaluated in a fully enrolled Phase 3 trial
Positive phase 3 ENHANCE results support proposed BRIUMVI single-dose initiation schedule
Late breaking oral presentation of Azer-cel to be presented Friday,
October 23, 2026
at
10:45am ET
NEW YORK
--(BUSINESS WIRE)--Oct. 21, 2026--
TG Therapeutics, Inc.
(NASDAQ: TGTX), today announced several updated poster presentations at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. The presentations include seven-year follow up data from the ULTIMATE I & II trials, Phase 1 subcutaneous BRIUMVI data, Phase 3 ENHANCE trial data, an update from the ENABLE real world study, and more presentations highlighting BRIUMVI data.
Additionally, the abstract is now available for the late-breaking oral presentation highlighting initial results from a Phase 1 study evaluating azer-cel in patients with primary progressive multiple sclerosis (PPMS). Links to the available data are included below along with key highlights.
Michael S. Weiss
, Chairman and Chief Executive Officer of
TG Therapeutics
, stated, “The breadth and consistency of the data presented at MSToronto2026 further reinforce our confidence in BRIUMVI as a leading treatment option for relapsing MS. The seven-year results are particularly compelling, with approximately 88% of continuously treated patients remaining free of confirmed disability progression, supported by an increasingly robust body of real-world evidence demonstrating strong disease control, favorable tolerability, and high patient satisfaction. We are also encouraged by emerging evidence from patients transitioning from other anti-CD20 therapies, which continues to inform our understanding of BRIUMVI’s differentiated clinical profile.”
Mr. Weiss
continued, “Equally exciting is the progress we are making toward the next generation of BRIUMVI. Our positive Phase 3 ENHANCE results support the potential to simplify IV treatment initiation to a single infusion, while our Phase 1 subcutaneous results provide strong support for the quarterly dosing regimen being evaluated in our fully enrolled Phase 3 trial. Together, these advances have the potential to strengthen our IV franchise while opening an entirely new segment of the anti-CD20 market, positioning BRIUMVI to become an increasingly important treatment option for patients with relapsing MS, regardless of their preferred route of administration.”
POSTER PRESENTATIONS & DATA HIGHLIGHTS:
Presentation Title:
Seven-Year Safety and Efficacy Outcomes for Ublituximab Treatment in Relapsing MS
BRIUMVI demonstrated sustained, robust efficacy through seven years of continuous treatment, with an annualized relapse rate (ARR) of 0.018 at Year 7
88.3% of patients receiving continuous BRIUMVI treatment remained free from 24-week confirmed disability progression at seven years. Only 11.7% experienced confirmed disability progression, compared with 17.4% of patients who initially received teriflunomide before switching to BRIUMVI (p=0.0148), supporting the thesis that early initiation of high-efficacy therapy may improve long-term disability outcomes. Additionally, 17.6% of continuously treated patients achieved confirmed disability improvement versus 13.6% in the switch group (p=0.0492).
BRIUMVI's safety profile remained consistent through seven years of treatment, with no apparent increase in exposure-adjusted adverse event rates over time.
Presentation Title:
Pharmacokinetic/Pharmacodynamic Evaluation of Ublituximab in Patients With Autoimmune Diseases
Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial.
Pharmacokinetic (PK) modeling and simulation informed by the Phase 1 bioavailability data support the quarterly subcutaneous dosing regimen that is being evaluated in the fully enrolled Phase 3 trial.
Presentation Title:
Randomized, Double-Blind Evaluation of a Consolidated Ublituximab Initial Dosing Regimen Versus Conventional Ublituximab Regimen
The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion 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.
Infusion Related Reactions (IRRs) were comparable for regimens and were lower than those reported in the ULTIMATE studies, with no Grade 3 or higher IRRs occurring in any participant.
Presentation Title:
Real-world Safety and Efficacy Outcomes in Relapsing Multiple Sclerosis Patients Initiating Ublituximab in the Phase 4 Observational Study ENABLE
In an updated analysis of 1,076 participants, 99.2% remained relapse-free during BRIUMVI treatment, with an ARR of 0.014.
First-dose infusion-related reactions occurred in 18.8% of participants, a lower rate than reported in the ULTIMATE studies. Median infusion times were 63 minutes for the second, third, and fourth infusions, supporting consistency of the one-hour infusion experience in clinical practice.
Presentation Title:
Ublituximab Mitigates Wearing-off Effect and Improves B-cell Depletion Among Participants Transitioning from Ocrelizumab: Updates from the ENHANCE Study
Among participants who reported wearing-off on ocrelizumab, switching to BRIUMVI was associated with a 69% reduction in reported wearing-off at Week 24, sustained through Week 48.
Among participants who were not B-cell depleted at the time of switching from a prior anti-CD20 antibody, 100% achieved B-cell depletion on BRIUMVI at Week 24 and 92.6% remained depleted at Week 48.
At least 98% of respondents reported positive ratings for convenience and ease of use at both Week 24 and Week 48.
Presentation Title:
Improvement in Wearing-Off Effect Correlates with Increased Tregs and Decreased Inflammatory Monocytes After Switch to Ublituximab in the ENHANCE Study
In an exploratory analysis of 20 participants switching from ocrelizumab, BRIUMVI treatment was associated with increased regulatory T cells and decreased inflammatory monocytes at Week 12, suggesting a shift toward a more anti-inflammatory immune profile.
These findings offer a potential biological explanation for improvements in wearing-off symptoms despite sustained peripheral B-cell depletion; treatment satisfaction was high in participants both with and without baseline wearing-off.
Presentation Title:
Fc Biology and Genetic Diversity in Multiple Sclerosis: A Multi-Center Study
A pilot analysis of 349 people with MS and 38 controls identified differences in Fc-receptor and IgG1 genetic variants across racial groups, including variants potentially relevant to antibody binding and recycling.
These preliminary findings support further investigation into how genetic variation may influence responses to monoclonal antibody therapies.
NEURAXPHARM-SPONSORED PRESENTATION
Presentation Title:
Real-world Data of Ublituximab in Relapsing Forms of Multiple Sclerosis: 48-Week Interim Results from the Non-interventional BRILL Study
In a 169-patient interim analysis, the proportion experiencing a relapse decreased by 93% compared with the 12 months before starting BRIUMVI, with an on-treatment ARR of 0.05.
Treatment satisfaction was high, with 94.6% of respondents indicating they would choose BRIUMVI again. Infusion-related reactions decreased from 21.9% at the first infusion to 3.0% at Week 48.
All posters are now available on the Publications page, located within the Pipeline section, of the Company’s website at
www.tgtherapeutics.com/publications.cfm
.
LATE-BREAKING ORAL PRESENTATION – ABSTRACT NOW AVAILABLE
Presentation Title:
First Clinical Evaluation of an Allogeneic CD19-Directed CAR T-Cell Therapy in Progressive Multiple Sclerosis: Initial Results from the Phase 1 TG-Azercel-101 Study
Presentation Date/Time:
Friday, October 23, 2026
from
10:45 - 10:55 AM ET
Session:
Late-Breaking Abstracts - Scientific Session
Abstract/Presentation Number:
Toronto-LBA-229 / Oral O135
Lead Author:
Daniel Ontaneda
, MD, PhD, Professor of Neurology, Cleveland Clinic Mellen Center
Following the presentation, 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.cfm
.
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 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.
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 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.
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 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
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 10%) were infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit
www.briumvi.com
.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here:
Briumvi |
European Medicines Agency
(europa.eu)
.
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 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 including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations 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 our plans, business strategies and operations related to the commercialization of BRIUMVI
®
(ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial 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 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 the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the uncertainties generally inherent in research and development, including the risk that the data from Phase 1 studies, including safety and efficacy, may not be replicated in registration directed or Phase 3 studies conducted in larger populations with longer follow-up; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; 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 SEC.
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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20261020332469/en/
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Email:
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Telephone: 1.877.575.TGTX (8489), Option 4
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Source: TG Therapeutics, Inc.
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