CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [2]

Active Indication

Multiple sclerosis relapseMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis+ [3]

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaB-Cell LymphomaB-cell lymphoma recurrent+ [34]

Originator Organization

Genmab A/S

Active Organization

Novartis Pharmaceuticals Corp.

Novartis AGNovartis Pharma AG

+ [3]

Inactive Organization

Genmab A/SGlaxoSmithKline Research & Development Ltd.

GlaxoSmithKline (China) Investment Co. Ltd.

+ [5]

License Organization

Genmab A/SNovartis Pharma AG

Novartis AG

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (26 Oct 2009),

Chronic Lymphocytic Leukemia

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States)

Structure/Sequence

Sequence Code 143593H

Source: *****

Sequence Code 143818L

Source: *****

201

Clinical Trials associated with Ofatumumab

NL-OMON61538

/ SuspendedNot Applicable

Detecting Outcomes with MRI and Fluid Biomarkers in Ofatumumab treated multiple sclerosis - DOMINO-MS: Detecting Outcomes with MRI and Fluid Biomarkers in Ofatumumab treated Multiple Sclerosis

Start Date12 Aug 2026

Sponsor / Collaborator-

NCT07625800

/ Not yet recruitingNot ApplicableIIT

Switch to Ofatumumab and Level of Immunoglobulins

This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.
The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.

Start Date01 Jun 2026

Sponsor / Collaborator-

NCT07546110

/ Not yet recruitingEarly Phase 1IIT

An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined With NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).

This is an Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined with NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).

Start Date01 May 2026

Sponsor / Collaborator

Affiliated Hospital of Xuzhou Medical University

100 Clinical Results associated with Ofatumumab

100 Translational Medicine associated with Ofatumumab

100 Patents (Medical) associated with Ofatumumab

888

Literatures (Medical) associated with Ofatumumab

01 Nov 2026·Multiple Sclerosis and Related Disorders

Long-term comparative outcomes in relapse activity and disability progression among anti-CD20 therapies in relapsing multiple sclerosis: An unanchored matching-adjusted indirect comparison

Article

Author: de Seze, Jerome ; Centonze, Diego ; Cutter, Gary ; Grigoriadis, Nikolaos ; Gold, Ralf ; Yamout, Bassem ; Javanbakht, Mehdi ; Selmaj, Krzysztof ; Hartung, Hans Peter ; Schmierer, Klaus ; Schmitt, Andreas B ; Barnett, Michael ; Miskin, Hari ; Ansaripour, Amir

BACKGROUND:

Anti-CD20 monoclonal antibodies are widely used in relapsing multiple sclerosis (RMS), but the absence of head-to-head randomized trials limits direct long-term comparisons between agents.

METHODS:

An unanchored matching-adjusted indirect comparison (MAIC) was conducted to explore five-year comparative outcomes in annualized relapse rate (ARR) and 24-week confirmed disability progression (CDP24) between ublituximab, ocrelizumab and ofatumumab. Individual patient data from the ULTIMATE I/II trials were reweighted to match published baseline characteristics from the OPERA I/II and ASCLEPIOS I/II trials. Long-term comparator outcomes were obtained from published follow-up data, with reconstruction of comparator patient-level data for time-to-event analyses where required. Sensitivity analyses included restricted mean survival time (RMST) for CDP24.

RESULTS:

MAIC-adjusted ublituximab ARR declined from 0.118 to 0.032 over five years versus ocrelizumab and from 0.116 to 0.030 versus ofatumumab. Ublituximab reduced the CDP24 hazard versus ocrelizumab (hazard ratio [HR] 0.560; 95% CI: 0.380-0.826) and ofatumumab (HR 0.509; 95% CI: 0.350-0.741), with 240-week RMST gains of 8 and 13 weeks, respectively.

CONCLUSIONS:

These findings suggest directionally favorable long-term outcomes with ublituximab compared with the other two comparators. These findings should be interpreted carefully within the assumptions and inherent limitations of the unanchored MAIC approach.

01 Nov 2026·JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY

Comparative effectiveness of ofatumumab and ocrelizumab in relapsing multiple sclerosis: a target trial emulation using multinational registry data

Article

Author: Thouvenot, Eric ; Kalincik, Tomas ; Jokubaitis, Vilija ; Ciron, Jonathan ; Vukusic, Sandra ; Heinzlef, Olivier ; Gerlach, Oliver ; Aboab, Jennifer ; Carroll, William M ; Baghbanian, Seyed Mohammad ; Brecl Jakob, Gregor ; David, Thomas ; Horakova, Dana ; Doghri, Ines ; Maillart, Elisabeth ; Al Khedr, Abdullatif ; Hankiewicz, Karolina ; Prat, Alexandre ; Monif, Mastura ; Creange, Alain ; Foong, Yi Chao ; John, Nevin ; Habek, Mario ; Manchon, Eric ; Alroughani, Raed ; Butzkueven, Helmut ; Le Page, Emanuelle ; Mathey, Guillaume ; Clavelou, Pierre ; Valero López, Gabriel ; D’Amico, Emanuele ; Moreau, Thibault ; Sarov Riviere, Mariana ; Papeix, Caroline ; Stetkarova, Ivana ; Moulin, Solène ; van der Walt, Anneke ; Labauge, Pierre ; De Sèze, Jérôme ; Skibina, Olga ; Bourre, Bertrand ; Zhou, Zhen ; Yetkin, Mehmet Fatih ; Pottier, Corinne ; Zephir, Helene ; Ampapa, Radek ; Nifle, Chantal ; Camdessanché, Jean-Philippe ; Defer, Gilles ; Laplaud, David-Axel ; Ruet, Aurelie ; Roos, Izanne ; Berger, Eric ; Lebrun-Frenay, Christine ; Laureys, Guy ; Magy, Laurent ; Merlo, Daniel ; Lechner-Scott, Jeannette ; Hodgkinson, Suzanne ; Ozakbas, Serkan ; Stourac, Pavel ; Zhu, Chao ; Casez, Olivier ; Kwiatkowski, Arnaud ; Kubala Havrdova, Eva ; Lapointe, Emmanuelle ; Kermode, Allan G ; Fabis-Pedrini, Marzena ; Tchikviladze, Maia ; Pelletier, Jean ; Meca-Lallana, Jose E ; Foschi, Matteo

Background:

Ofatumumab and ocrelizumab are widely used high-efficacy anti-CD20 therapies for relapsing-remitting multiple sclerosis (RRMS), but direct comparative evidence remains limited. We aimed to compare their effectiveness in routine clinical practice.

Methods:

We conducted an observational cohort study emulating a target trial using data from the MSBase and Observatoire Français de la Sclérose en Plaques registries (January 2021 to December 2024). Adults with RRMS initiating ofatumumab or ocrelizumab were included. Patients were matched 1:1 using propensity scores. Primary outcomes were annualised relapse rate (ARR) and time to first relapse. Secondary outcomes included time to confirmed disability progression (CDP), progression independent of relapse activity (PIRA), confirmed disability improvement (CDI), MRI activity and treatment discontinuation. Negative binomial and Cox regression models were applied.

Results:

A total of 5288 patients were matched with a median follow-up of 1.2 years for ofatumumab and 1.4 years for ocrelizumab. ARR was 0.07 (95% CI 0.05 to 0.08) with ofatumumab and 0.04 (0.03 to 0.05) with ocrelizumab, corresponding to an ARR ratio of 1.75 (1.43 to 2.13). Ofatumumab was associated with a lower risk of CDP (HR 0.66; 0.49 to 0.87) and PIRA (0.53; 0.39 to 0.73), but a lower probability of CDI (0.76; 0.60 to 0.96). No significant differences were observed in MRI activity or treatment discontinuation.

Conclusions:

Both therapies were highly effective in a large cohort of patients with RRMS, with very low relapse or CDP rates. Ofatumumab was associated with slightly greater disability control, while ocrelizumab more effectively suppressed relapses. These differences were modest, and their clinical relevance requires further evidence and should be interpreted with caution.

01 Nov 2026·Neurology-Neuroimmunology & Neuroinflammation

Disease Activity During Pregnancy and Postpartum in Women With Multiple Sclerosis Treated With Ocrelizumab or Rituximab Before Pregnancy

Article

Author: Gold, Ralf ; Witt, Laura ; Thiel, Sandra ; Haben, Sabrina ; Bast, Nadine ; Hellwig, Kerstin ; Dost-Kovalsky, Karen

BACKGROUND AND OBJECTIVES:

Preliminary data suggest sustained disease control with ocrelizumab (OCR) or rituximab (RTX) in women with multiple sclerosis (MS) after pregnancy suspension; however, the influence of washout duration and cumulative dosing remains unknown. This study investigates disease activity during and after pregnancy in women with relapsing-remitting MS treated with OCR/RTX before pregnancy.

METHODS:

In this cohort study, pregnancies of women treated with OCR/RTX documented in the German MS and Pregnancy Registry were stratified by timing of last infusion (≥ or <4 months to last menstrual period [LMP]) and number of cycles (≥ or <2 cycles). Relapses treated with high-dose glucocorticosteroids were analyzed, as was persistent disability (following a relapse) at 1-year postpartum, defined as a ≥2.0-point increase in Expanded Disability Status Scale (EDSS) or new/worsening ambulatory impairment (Severe Relapse Disability Composite Score [SRDCS]).

RESULTS:

Of 294 pregnancies among 275 women, only 28.6% (n = 84) suspended OCR/RTX ≥4 months before LMP and most (79.3% [n = 233]) received ≥2 cycles. Relapses during pregnancy (2.0%) and within 12 months postpartum (8.5%) were rare. Four women (1.6%) reached the SRDCS postpartum. Neither the time of last infusion nor the number of cycles was associated with a higher relapse risk during pregnancy (time between OCR/RTX and LMP: <4 months adjusted OR: 0.60, CI: 0.09-5.02, p value: 0.60; number of cycles: <2 cycles adjusted OR: 2.23, CI: 0.34-15.5, p value: 0.39) or postpartum (time between OCR/RTX and LMP: <4 months adjusted OR: 0.62, CI: 0.23-1.77, p value: 0.36; number of cycles: <2 cycles adjusted OR: 0.64, CI: 0.16-2.03, p value: 0.48, time of anti-CD20 antibody restart postpartum: >6 weeks adjusted OR: 1.15, CI: 0.37-4.11, p value: 0.82) or with reaching the SRDCS or EDSS worsening postpartum. In women receiving ≥2 cycles and interrupting treatment <4 months before LMP, numerically fewer relapses during pregnancy could be observed (1/163: 0.6% vs 5/131: 3.8%, p value: 0.09).

DISCUSSION:

Relapses and disability during and after pregnancy after OCR/RTX interruption are rare and independent of timing and number of cycles. However, potential differences may not be detectable due to the low number of events and should be evaluated in larger studies. In addition, the applicability to ofatumumab, given its different dosing interval, remains unclear.

213

News (Medical) associated with Ofatumumab

21 Oct 2026

·www.gene.com

Genentech Presents New Pivotal Trial Data Across Broad Neuroimmunology Portfolio at MSToronto2026

Wednesday, Oct 21, 2026 Fenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS) Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualized relapse rate (ARR) vs active comparator Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years, reinforcing consistent MS control across all ages Featured in "Best of MSToronto2026," Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease South San Francisco, CA -- October 21, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators. These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS-ECTRIMS Meeting), held October 21 to 23 in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the “Best of MSToronto2026.” “Addressing long-term disability progression to preserve people’s independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis.” Fenebrutinib targets progressive biology inside the brain New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS. Reduction of chronic active lesions (Late-breaking oral #O137): In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p<0.001) in RMS (over 96 weeks) and PPMS (over 120 weeks), along with a 62% (p=0.001) reduction in accumulation of paramagnetic rim lesions (PRLs) in RMS, versus active comparators. These findings demonstrate that fenebrutinib directly targets chronic neuroinflammation in the brain, a primary driver of disability progression in MS. Comprehensive disease control (Poster #P1434): In the pooled RMS trials, three quarters (75%) of fenebrutinib-treated patients showed no evidence of disease activity (NEDA-3) meaning zero relapses, zero MRI activity and zero worsening disability at nearly two years, a 70% reduction (p<0.001) versus the comparator. These results show fenebrutinib’s potential to suppress disease activity and delay progression. Preserving brain volume and function (Oral #O089): Pooled RMS data show fenebrutinib reduced the annualized relapse rate (ARR) by 55% versus the comparator (p<0.001) over 96 weeks. In addition, fenebrutinib reduced annual total brain volume loss by 23% (p<0.001) and 12-week composite confirmed disability progression by 16% (p=0.04). These findings demonstrate fenebrutinib’s potential to control relapses, to slow brain tissue loss caused by neuronal cell death and to preserve function. Ocrevus provides consistent benefits across all age groups New data show that Ocrevus provides significant and consistent efficacy across a broad MS patient population, from children 10 years of age to older adults. Two-year data and immune function in pediatric MS (Three posters on the Phase III OPERETTA 2 study): 90% of children with relapsing-remitting MS (RRMS) treated with Ocrevus, who were 10-17 years old at trial entry, remained free of relapses over two years (#P1439). Ocrevus selectively depleted target B cells with little to no effect on other immune cells (#P1407), while preserving pre-existing immunity to common childhood vaccines in 81–100% of patients (#P1415). Two-year data in patients >55 years old (Poster #P1426 on the Phase IIIb CONSONANCE study): 53% of participants over 55 years old treated with Ocrevus showed no disability progression after two years, similarly to younger participants (55%), showing Ocrevus maintains its effect on progression as people age. Switching from other treatments to Ocrevus: Real-world data show progression was the leading reason for patients switching from ofatumumab to Ocrevus (ePoster #EP2733). A separate analysis of patients treated with Ocrevus or ofatumumab for one year show Ocrevus was associated with lower MRI lesion activity (Poster #P0305). Enspryng reduces risk of attack and is associated with improved recovery Exploratory analyses of the pivotal METEOROID trial suggest that in addition to significantly lowering the risk of relapse (AAN 2026), Enspryng was associated with improved recovery and reduced disability progression, which is critical to prevent permanent damage to the optic nerves, spinal cord or brain in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). These findings reinforce Enspryng’s potential to become the first FDA-approved treatment for MOGAD, with a decision in the U.S. expected in January 2027. Relapse recovery (Oral #O035): Patients treated with Enspryng achieved numerically superior recovery at 12 weeks post relapse versus placebo (median change in Expanded Disability Status Scale [EDSS] of -2 vs -0.5). Overall function was stable (median 0) with Enspryng, compared to worsening (median 0.5) with placebo, as measured with the EDSS at the end of the double-blind period or first relapse. About fenebrutinib Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. About Ocrevus® (ocrelizumab) Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months. About Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signaling, a key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signaling. Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety profile in over 16,000 patients. Enspryng was also recently approved for the treatment of thyroid eye disease (TED) in the U.S. Genentech is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). About Genentech in Neurology Neurology is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Genentech and Roche are investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. About Genentech Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. Indications and Important Safety Information What is Ocrevus? Ocrevus is a prescription medicine used to treat: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Primary progressive MS, in adults. Relapsing-remitting MS, in children 10 years of age and older who weigh 55 pounds (25 kg) or more. It is not known if Ocrevus is safe and effective in children younger than 10 years of age or who weigh less than 55 pounds (25 kg).  Who should not receive Ocrevus? Do not receive Ocrevus if you: have an active hepatitis B virus (HBV) infection. have had a life-threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past. What is the most important information I should know about Ocrevus? Ocrevus can cause serious side effects, including: Infusion reactions: Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms: Itchy skin Rash Hives Tiredness Coughing or wheezing Trouble breathing Throat irritation or pain Feeling faint Fever Redness on your face (flushing) Nausea Headache Swelling of the throat Dizziness Shortness of breath Fatigue Fast heart beat These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion. Infection: Infections are a common side effect. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone. Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus. Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections. Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with: Thinking Eyesight Strength Balance Weakness on 1 side of your body Using your arms or legs Decreased immunoglobulins: Ocrevus may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels. Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you: have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. have ever had hepatitis B or are a carrier of the hepatitis B virus. have a history of inflammatory bowel disease or colitis. have a history of liver problems. have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened. When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus, talk to your healthcare provider. If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus so they can decide when your baby should be vaccinated. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus. are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of Ocrevus? Ocrevus may cause serious side effects, including: Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer. Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as: Diarrhea (loose stools) or more frequent bowel movements than usual Stools that are black, tarry, sticky or have blood or mucus Severe stomach-area (abdomen) pain or tenderness Liver damage. Ocrevus may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus and while you take Ocrevus if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as: yellowing of the skin and eyes (jaundice) nausea vomiting unusual darkening of the urine feeling tired or weak loss of appetite discomfort in the upper right area of stomach (abdomen) These are not all the possible side effects of Ocrevus. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555. For more information, go to https://www.Ocrevus.com or call 1-844-627-3887. For additional safety information, please see the full Prescribing Information and Medication Guide. Indications and Important Safety Information What is Enspryng? Enspryng is a prescription medicine used to treat: neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive. thyroid eye disease (TED) no matter how severe it is or how long a person has had it. It is not known if Enspryng is safe and effective in children. Who should not receive Enspryng? Do not take Enspryng if you: are allergic to Enspryng or any of the ingredients in Enspryng. have an active hepatitis B infection. have active or untreated inactive (latent) tuberculosis. What is the most important information I should know about Enspryng? Enspryng may cause serious side effects including: Infections. Enspryng can increase your risk of serious infections, some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection, or call them right away if you think you have signs of an infection, with or without a fever, such as: chills, feeling tired, muscle aches, cough that will not go away or a sore throat skin redness, swelling, tenderness, pain or sores on your body diarrhea, belly pain, or feeling sick burning when you urinate or urinating more often than usual Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take Enspryng. Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking Enspryng. All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start Enspryng. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start Enspryng. Increased liver enzymes. Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking Enspryng. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start Enspryng if your liver enzymes are increased. Low neutrophil count. Enspryng can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking Enspryng. Serious allergic reactions. Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction, such as: shortness of breath or trouble breathing dizziness or feeling faint swelling of your lips, face, or tongue moderate or severe stomach (abdominal) pain or vomiting chest pain Before you take Enspryng, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection. See "What is the most important information I should know about Enspryng?" have liver problems. have ever had hepatitis B or are a carrier of the hepatitis B virus. have had or have been in contact with someone with tuberculosis. have had a recent vaccination or are scheduled to receive any vaccination. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Enspryng will harm your unborn baby. Pregnancy Registry: There is a registry for pregnant women who take Enspryng. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Enspryng, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-833-277-9338 to enroll. are breastfeeding or plan to breastfeed. It is not known if Enspryng passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Enspryng. Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the most common side effects of Enspryng? The most common side effects of Enspryng include: sore throat, runny nose (nasopharyngitis) rash fatigue extremity pain headache upper respiratory tract infection nausea inflammation of the stomach lining (gastritis) joint pain (arthralgia) These are not all the possible side effects of Enspryng. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555. For more information, go to https://www.Enspryng.com/ or call 1-844-NSPRYNG. For additional safety information, please see the full Prescribing Information and Medication Guide. ###

Clinical ResultPhase 3Drug ApprovalPhase 2

21 Oct 2026

·www.biospace.com

Roche presents new pivotal trial data across broad neuroimmunology portfolio at MSToronto2026

Fenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS) Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualised relapse rate (ARR) vs active comparator Following European Commission paediatric approval on 15 October, new Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years Featured in "Best of MSToronto2026", Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease Basel, 21 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators. 1-3 These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS- ECTRIMS Meeting), held 21 to 23 October in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the “Best of MSToronto2026. 4 “Addressing long-term disability progression to preserve people’s independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis.” Fenebrutinib targets progressive biology inside the brain New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS. Reduction of chronic active lesions (Late-breaking oral #O137) : In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p55 years old (Poster #P1426 on the Phase IIIb CONSONANCE study): 53% of participants over 55 years old treated with Ocrevus showed no disability progression after two years, similarly to younger participants (55%), showing Ocrevus maintains its effect on progression as people age. 8 Switching from other treatments to Ocrevus : Real-world data show progression was the leading reason for patients switching from ofatumumab to Ocrevus ( ePoster #EP2733 ). 9 A separate analysis of patients treated with Ocrevus or ofatumumab for one year show Ocrevus was associated with lower MRI lesion activity ( Poster #P0305 ). 10 Enspryng reduces risk of attack and is associated with improved recovery Exploratory analyses of the pivotal METEOROID trial suggest that in addition to significantly lowering the risk of relapse ( AAN 2026 ), Enspryng was associated with improved recovery and reduced disability progression, which is critical to prevent permanent damage to the optic nerves, spinal cord or brain in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). These findings reinforce Enspryng’s potential to become the first FDA-approved treatment for MOGAD, with a decision in the U.S. expected in January 2027. 4,11 Relapse recovery (Oral #O035): Patients treated with Enspryng achieved numerically superior recovery at 12 weeks post relapse versus placebo (median change in Expanded Disability Status Scale [EDSS] of -2 vs -0.5). Overall function was stable (median 0) with Enspryng, compared to worsening (median 0.5) with placebo, as measured with the EDSS at the end of the double-blind period or first relapse. 4 About fenebrutinib Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. About Ocrevus® (ocrelizumab) Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months. About Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling. Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety pro over 16,000 patients. Enspryng was also recently approved for the treatment of thyroid eye disease (TED) in the U.S. Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). About Roche in Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Oh J, et al. Fenebrutinib Shows a Therapeutic Effect on MS Progressive Biology: Outcomes on Paramagnetic Rim Lesions and Slowly Expanding Lesions in the Phase III FENhance I/II and FENtrepid Trials in Relapsing and Primary Progressive Multiple Sclerosis (#O137). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 23 October 2026; Toronto, Canada. [2] Cerqueira JJFCA, et al. No Evidence of Disease Activity With Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results From the Phase III FENhance 1 and 2 Trials (#P1434). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [3] Sormani MP, et al. Efficacy of Fenebrutinib Versus Teriflunomide in Relapsing Multiple Sclerosis: Pooled Analysis Results From the FENhance 1 and 2 Studies (#O089). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [4] Marignier R, et al. Severity and Recovery of Relapses in Patients with Relapsing MOGAD Treated with Satralizumab: Results from the Phase 3 METEOROID Study (#O035). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [5] Deiva K, et al. OPERETTA 2: Continued Follow-Up of the Efficacy and Safety Pro Ocrelizumab in Pediatric Relapsing-Remitting MS (#P1439). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [6] Bar-Or A, et al. Impact of Ocrelizumab vs Fingolimod on Immune Function in Pediatric Patients With MS in the OPERETTA 2 Study (#P1407). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [7] Banwell B, et al. Vaccination and Disease-Modifying Therapies: Impact of Ocrelizumab vs Fingolimod on Preexisting Vaccine Seropositivity and Vaccine-Preventable Infections in Pediatric Patients With MS in OPERETTA 2 (#P1415). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [8] Butzkueven H, et al. Ocrelizumab Maintains Clinical and Safety Outcomes in Older Patients (>55 Years) with Progressive Multiple Sclerosis: 2-Year Results from the CONSONANCE Study (#P1426). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [9] Marriott J, et al. Switching Patients with Multiple Sclerosis from Ofatumumab to Ocrelizumab: A Real-World Study of Canadian Healthcare Professionals (#EP2733). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21-23 October 2026; Toronto, Canada. [10] Ziemssen T, et al. Brain Volume Loss and T2 Lesion Activity in RRMS: Real-World Longitudinal Comparison of Ocrelizumab vs. Ofatumumab (#P0305). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [11] Levy M, et al. Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial (PL5.006). Presented at: 78th Annual Meeting of the American Academy of Neurology (AAN) 2026; 21 April 2026; Chicago, IL, USA. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75 Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment Media&Investor Release MSToronto2026 English

Clinical ResultPhase 3Drug Approval

12 Oct 2026

·www.biospace.com

TG Therapeutics Announces Publication of Five-Year Comparative Analysis of BRIUMVI Versus Ocrelizumab and Ofatumumab in Relapsing Multiple Sclerosis

BRIUMVI was associated with a lower risk of 24-week confirmed disability progression and lower annualized relapse rates (ARRs) over five years compared with ocrelizumab and ofatumumab NEW YORK--(BUSINESS WIRE)-- $TGTX --TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the publication of results from a five-year matching-adjusted indirect comparison (MAIC) evaluating long-term relapse activity and disability progression outcomes with BRIUMVI ® (ublituximab-xiiy) compared with ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis (RMS). For the analysis, individual patient data from the Phase 3 ULTIMATE I/II pivotal trials for BRIUMVI were reweighted to match published baseline characteristics from the pivotal studies for ocrelizumab and ofatumumab in patients with RMS, revealing favorable long-term outcomes with BRIUMVI compared to the other two comparators. The manuscript, entitled “Long-Term Comparative Outcomes in Relapse Activity and Disability Progression Among Anti-CD20 Therapies in Relapsing Multiple Sclerosis: An Unanchored Matching-Adjusted Indirect Comparison,” was published online in Multiple Sclerosis and Related Disorders . Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “In an era where physicians and patients are fortunate to have multiple anti-CD20 treatment options available for relapsing MS, the lack of comparative data makes choosing the right one challenging. This is particularly important for people living with a chronic disease like MS, where preventing the accumulation of disability over time is an important treatment goal.” Mr. Weiss continued, “In the absence of head-to-head clinical trials, MAIC provides a valuable statistical approach to evaluating comparative treatment outcomes while accounting for differences in patient populations across studies. We are encouraged that this analysis showed that BRIUMVI was associated with consistently lower relapse activity versus ocrelizumab and a lower risk of confirmed disability progression compared with both ocrelizumab and ofatumumab over five years. We believe these findings add to the growing body of evidence supporting the durable efficacy pro BRIUMVI and its potential to provide meaningful long-term benefit for people living with MS.” The manuscript can be accessed at ScienceDirect.com or on the publications page of the TG corporate website at Key Findings from the Publication Five-year anti-CD20 outcomes from the pivotal studies of BRIUMVI, ocrelizumab, and ofatumumab were compared using an unanchored MAIC (see below for more information about the MAIC). The analysis used individual patient-level data from 545 BRIUMVI (ublituximab)-treated participants in the Phase 3 ULTIMATE I and II trials and their open-label extension and compared outcomes with published aggregate data from the Phase 3 OPERA I/II trials of ocrelizumab and ASCLEPIOS I/II trials of ofatumumab. In the analysis, BRIUMVI patient-level data were re-weighted to align baseline characteristics with the respective comparator trial populations. These adjustments are designed to mitigate the effects of any demographic differences in the study populations on the efficacy results. The findings included: BRIUMVI was associated with a lower risk of 24-week confirmed disability progression (CDP24) compared with both ocrelizumab and ofatumumab, with a 44% lower relative hazard versus ocrelizumab (HR 0.560; 95% CI: 0.380–0.826) and a 49% lower relative hazard versus ofatumumab (HR 0.509; 95% CI: 0.350–0.741). BRIUMVI was associated with a lower cumulative incidence of CDP24 at 240 weeks, with estimated rates of 9.3% versus 16.1% for ocrelizumab and 9.4% versus 17.9% for ofatumumab. BRIUMVI was associated with more time free from confirmed disability progression over 240 weeks, with an average of 8.1 additional weeks compared with ocrelizumab (95% CI: 2.3–14.1) and 13.1 additional weeks compared with ofatumumab (95% CI: 6.7–19.3). BRIUMVI demonstrated consistently low annualized relapse rates (ARR) over five years of treatment, with MAIC-adjusted ARR declining from 0.118 in Year 1 to 0.032 in Year 5 in the comparison with ocrelizumab, and from 0.116 to 0.030 in the comparison with ofatumumab. These findings are considered exploratory and require confirmation in direct comparative studies. About the MAIC Analysis In the absence of randomized head-to-head trials directly comparing anti-CD20 therapies in RMS, investigators conducted an unanchored MAIC to explore comparative outcomes over five years. Individual patient data from the pivotal Phase 3 ULTIMATE I and II studies were reweighted to match published baseline characteristics from the pivotal Phase 3 studies for ocrelizumab (OPERA I/II) and ofatumumab (ASCLEPIOS I/II), including age, sex, baseline Expanded Disability Status Scale (EDSS) score, gadolinium-enhancing lesion prevalence, T2 lesion volume, prior relapse activity and time since diagnosis, where corresponding data were available. Following weighting, baseline characteristics were closely aligned with both comparator populations. The authors note that the findings should be interpreted within the inherent limitations of an unanchored MAIC. Notably, the methodology cannot adjust for unmeasured differences between trials, and residual confounding cannot be excluded. Accordingly, the analysis is exploratory and the findings require confirmation through direct comparative studies or robust real-world evidence. The study was funded by Neuraxpharm, TG Therapeutics' European commercialization partner for BRIUMVI. 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 (NCT03277261; NCT03277248). 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 and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn . BRIUMVI ® is a registered trademark of TG Therapeutics, Inc. 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 . 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 . 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 . 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 85% are initially diagnosed with RRMS. 1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS. 1 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 potential significance and implications of the published results; the potential for BRIUMVI (ublituximab-xiiy) to provide meaningful long-term benefit for people living with relapsing multiple sclerosis (RMS); the potential for the published findings to support the efficacy profile, differentiation, utilization, acceptance or commercial opportunity for BRIUMVI; and expectations regarding the continued commercialization, healthcare professional and patient acceptance, and use of BRIUMVI in the United States and jurisdictions outside the United States. Additional factors that could cause actual results to differ materially include: the inherent limitations of matching-adjusted indirect comparisons and other cross-trial analyses; the risk that the results of the analysis may not be confirmed in other clinical studies or real-world evidence; the risk that differences in trial design, patient populations, treatment exposure, follow-up, unmeasured or unavailable prognostic factors, treatment effect modifiers, or other sources of residual confounding may affect the interpretation of the results; the risk that the results may not be indicative of outcomes in broader patient populations or clinical practice; and the uncertainties generally inherent in research and development and the interpretation of clinical and comparative effectiveness data. 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 . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. 1. MS Prevalence. National Multiple Sclerosis Society website. . Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236. Contacts 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

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Ofatumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09314	Ofatumumab	L01FA02	DB06650

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple sclerosis relapse	European Union	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Iceland	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Liechtenstein	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Norway	Novartis Europharm Ltd.	26 Mar 2021
Multiple Sclerosis, Relapsing-Remitting	Canada	Novartis Pharmaceuticals Canada, Inc.	22 Jan 2021
Multiple Sclerosis, Relapsing-Remitting	Canada	Novartis Pharma AG	22 Jan 2021
Multiple Sclerosis	United States	Novartis Pharmaceuticals Corp.	20 Aug 2020
Lymphoid Leukemia	Japan	Novartis Pharma AG	23 Mar 2013
Chronic Lymphocytic Leukemia	United States	Novartis Pharmaceuticals Corp.	26 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rhabdomyosarcoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Bulgaria	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Czechia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Estonia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Germany	Novartis Pharmaceuticals Corp.	14 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04353492 (ARTIOS, Pubmed \| J Neurol)	Phase 3	-	562	Ofatumumab	tanryqdtdj(okndsqzxzm) = hrtofbgjpk fkutwdoaga (wktyvjarts ) View more	Positive	01 Jul 2026
EAN2026	Not Applicable	Multiple Sclerosis	473	Ofatumumab	vzqhbvxuut(asmiaoxhfl) = lwnskkdgks faiwvykskq (yecyxlbirh ) View more	Positive	26 Jun 2026
NCT06867991 (RADIA, Pubmed \| Front Neurol)	Phase 3	Autoimmune Encephalitis	200	Ofatumumab+Daratumumab	rufvrgsdeq(iitciqvuho) = uweenumrni igwebcckxr (bfuomxzmzp ) View more	Positive	29 May 2026
NCT06867991 (RADIA, Pubmed \| Front Neurol)	Phase 3	Autoimmune Encephalitis	200	Ofatumumab	dbxrglpdgi(omxrguashi) = hyvglbjzxq ivfsfbyzkw (onzbjbdnvb ) View more	Positive	29 May 2026
PRIM (AAN2026)	Not Applicable	Multiple sclerosis relapse	906	Ofatumumab	mghkkfpxer(bgrfgnmmvq) = prnkmdhbsj itxlkpzhod (avgcbtqgve ) View more	Positive	25 Apr 2026
AAN2026	Not Applicable	Multiple Sclerosis	329	Ofatumumab	qtelbfsemx(bmwigtkdrq) = igjksxgqcf nnjncaqrna (ibdaouirsl ) View more	Positive	25 Apr 2026
CRONOS (ACTRIMS2026)	Not Applicable	Multiple sclerosis relapse	310	Ofatumumab	gaugfnajje(cmiuqtkuaw) = ghmrakgcin gmyfbkmoil (wnnkzqgdmn ) View more	Positive	05 Feb 2026
NCT04486716 (OLIKOS, ACTRIMS2026)	Phase 3	Multiple sclerosis relapse	102	Ofatumumab 20 mg SC	toliovqeyj(eoevwrkhow) = watknwfjax yaszjtcupx (qxcfyqhoas ) View more	Positive	05 Feb 2026
ASCLEPIOS I (ACTRIMS2026)	Phase 3	Rhabdomyosarcoma	261	Ofatumumab	uuulfeibvx(jalvfemimx) = jtzjdaligu xedzlfnfil (hkavfnzqgj ) View more	Positive	05 Feb 2026
ASCLEPIOS I (ACTRIMS2026)	Phase 3	Rhabdomyosarcoma	261	Teriflunomide	uuulfeibvx(jalvfemimx) = rhuhjqcctp xedzlfnfil (hkavfnzqgj ) View more	Positive	05 Feb 2026
ACTRIMS2026	Not Applicable	Multiple sclerosis relapse First line	497	Ofatumumab	myqnadbxse(vhptrmwspu) = xllakoonps hhlxfdmhco (iuxuubwdfm ) View more	Positive	05 Feb 2026
ACTRIMS2026	Not Applicable	Multiple sclerosis relapse First line	497	IFN or GA	myqnadbxse(vhptrmwspu) = ituqrxkusg hhlxfdmhco (iuxuubwdfm ) View more	Positive	05 Feb 2026
NCT04353492 (ARTIOS，COMB157G23101 \| COMB157G23101 \| ARTIOS, CTgov)	Phase 3	Rhabdomyosarcoma \| Multiple sclerosis relapse	562	Ofatumumab	rebdfkjqas = hnfdykoshy ilaxtzgppd (jsuwfrjqvz, ovageinqiw - ftjqlrulzr) View more	-	12 Nov 2025

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