{"success":true,"data":{"pressRelease":{"id":"4464","rtpr_id":"nGNX8mxst8","ticker":"TGTX","exchange":"NASDAQ","all_tickers":["TGTX"],"title":"TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2026 Annual Meeting","author":"Globe Newswire","published_at":"2026-04-22T11:30:00.593Z","article_body":"NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:\nTGTX), today announced the presentation of data highlighting BRIUMVI(®)\n(ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis\n(RMS), at the American Academy of Neurology 2026 annual meeting in Chicago.\nLinks to each presentation are included below.\n\nMichael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics\nstated, “We are excited to present new data at AAN 2026 further supporting\nthe differentiated profile of BRIUMVI for people living with relapsing\nmultiple sclerosis. The results from the ENABLE and ENHANCE studies continue\nto build on our growing body of evidence demonstrating the real-world\neffectiveness, safety, and tolerability of BRIUMVI, and provide insights into\noptimized dosing approaches for IV BRIUMVI, respectively. We look forward to\ncontinuing to expand the clinical and real-world data supporting BRIUMVI as an\nimportant treatment option in adults with RMS.”\n\nTG PRESENTATIONS:\n\nPoster Presentation Title: Real World Clinical Experience from ENABLE, the\nFirst Phase 4 Observational Study for Patients with Relapsing Multiple\nSclerosis Initiating Ublituximab\n(https://www.globenewswire.com/Tracker?data=oezN8BMeEzpL23fXi7hV6P-mmYfavhyCdK7tVAFpXZEdCvvpGBbX-DNVCdk7lXF9HyoO0R3ZKwOnL9vhzRK1-xHCItZVM8aDiSZF8s0inkhRhcRNh0uedxW9BeO5N3Qcuw2YCrVkXSd7Sfh2Xt3D0aa0OrmDJRdYpWsCKOZZqNkJsZEFbGw2jUlTUM95fyhqXxDRVFemHrXZNN44uzxGKzhNIbKjv7WILX6HpYne9IeyXfQHwRDC4CKEnEwuJTqjPFL5x7a7TCx-TVg1RngM7AXDmVYtLNfR4rN-fkX7DGu6jNqpkLlxhpSa8uyWpvob4HdsWiFUIHho1EqPcWXlLdhaZtMhpKO-EU6r9FEmoq0=)\n\nLead Author: Carrie Hersh, DO, MSc, FAAN - Cleveland Clinic Lou Ruvo Center\nfor Brain Health (CCLRCBH) (MS) & Neuroimmunology Specialist – Assoc.\nProfessor of Neurology at Cleveland Clinic Lerner College of Medicine of Case\nWestern Reserve University\n\nPoster Presentation Title: Safety and Tolerability of a Modified Ublituximab\nDosing Regimen: Updates from the ENHANCE Study\n(https://www.globenewswire.com/Tracker?data=EBkjUKAgMXHNONcNs39ePJGE2vcuXqFnafu71G_mfOyfCRPK3ocxOtBcdpdWEJbhwqHGWfGSwBstLyPHaRe6HYMqhfIPAfUKDLhPbKiuiydss26OpVcbMD_v1etj0tl9cgsNFW8XadB3gW_a2gtJp9H6kAVMboYcNS1YcgygJprDnovRyjdFTBiWhvxagxzpRyGqxQHamFFRBP69tBS3HB6rpT_ALOmLyqXAD0D8ETexOE-ZSS_-LuIS15OJ4Fk2mz_A3KlB6S3GvjYPKQd1DQ==)\n\nLead Author: Barry A. Singer, MD - Director, The MS Center for Innovations in\nCare - Missouri Baptist Medical Center, St. Louis, MO, United States\n\nThe above presentations are also available on the Publications page, located\nwithin the Pipeline section, of the Company’s website at\nwww.tgtherapeutics.com/publications/.\n\nABOUT BRIUMVI(®) (ublituximab-xiiy) 150 mg/6 mL Injection for IV\nBRIUMVI is a novel monoclonal antibody that targets a unique epitope on\nCD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven\nto be an important therapeutic approach for the management of autoimmune\ndisorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar\nmolecules normally expressed on the antibody. Removal of these sugar\nmolecules, a process called glycoengineering, allows for efficient B-cell\ndepletion at low doses. \n\nBRIUMVI is indicated in the U.S. for the treatment of adults with RMS,\nincluding clinically isolated syndrome, relapsing-remitting disease, and\nactive secondary progressive disease and in several countries outside of the\nU.S. for the treatment of adult patients with RMS with active disease defined\nby clinical or imaging features.\n\nA list of authorized specialty distributors can be found at www.briumvi.com.\n\nIMPORTANT SAFETY INFORMATION\nContraindications: BRIUMVI is contraindicated in patients with:\n* Active Hepatitis B Virus infection\n* A history of life-threatening infusion reaction to BRIUMVI\nWARNINGS AND PRECAUTIONS\n\nInfusion Reactions: BRIUMVI can cause infusion reactions, which can include\npyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat\nirritation, erythema, and an anaphylactic reaction. In MS clinical trials, the\nincidence of infusion reactions in BRIUMVI-treated patients who received\ninfusion reaction-limiting premedication prior to each infusion was 48%, with\nthe highest incidence within 24 hours of the first infusion. 0.6% of\nBRIUMVI-treated patients experienced infusion reactions that were serious,\nsome requiring hospitalization.\n\nObserve treated patients for infusion reactions during the infusion and for at\nleast one hour after the completion of the first two infusions unless infusion\nreaction and/or hypersensitivity has been observed in association with the\ncurrent or any prior infusion. Inform patients that infusion reactions can\noccur up to 24 hours after the infusion. Administer the recommended\npre-medication to reduce the frequency and severity of infusion reactions. If\nlife-threatening, stop the infusion immediately, permanently discontinue\nBRIUMVI, and administer appropriate supportive treatment. Less severe infusion\nreactions may involve temporarily stopping the infusion, reducing the infusion\nrate, and/or administering symptomatic treatment.\n\nInfections: Serious, life-threatening or fatal, bacterial and viral infections\nhave been reported in BRIUMVI-treated patients. In MS clinical trials, the\noverall rate of infections in BRIUMVI-treated patients was 56% compared to 54%\nin teriflunomide-treated patients. The rate of serious infections was 5%\ncompared to 3% respectively. There were 3 infection-related deaths in\nBRIUMVI-treated patients. The most common infections in BRIUMVI-treated\npatients included upper respiratory tract infection (45%) and urinary tract\ninfection (10%). Delay BRIUMVI administration in patients with an active\ninfection until the infection is resolved.\n\nConsider the potential for increased immunosuppressive effects when initiating\nBRIUMVI after immunosuppressive therapy or initiating an immunosuppressive\ntherapy after BRIUMVI.\n\nHepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS\npatient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic\nfailure, and death caused by HBV reactivation have occurred in patients\ntreated with anti-CD20 antibodies. Perform HBV screening in all patients\nbefore initiation of treatment with BRIUMVI. Do not start treatment with\nBRIUMVI in patients with active HBV confirmed by positive results for HB\nsurface antigen (HBsAg) and anti-HB tests. For patients who are negative for\nHBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV\n[HBsAg+], consult a liver disease expert before starting and during treatment.\n\nProgressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic\nviral infection of the brain caused by the JC virus (JCV) that typically only\noccurs in patients who are immunocompromised, and that usually leads to death\nor severe disability. JCV infection resulting in PML has been observed in\npatients treated with anti-CD20 antibodies, including BRIUMVI, and other MS\ntherapies.\n\nIf PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic\nevaluation. Typical symptoms associated with PML are diverse, progress over\ndays to weeks, and include progressive weakness on one side of the body or\nclumsiness of limbs, disturbance of vision, and changes in thinking, memory,\nand orientation leading to confusion and personality changes.\n\nMRI findings may be apparent before clinical signs or symptoms; monitoring for\nsigns consistent with PML may be useful. Further investigate suspicious\nfindings to allow for an early diagnosis of PML, if present. Following\ndiscontinuation of another MS medication associated with PML, lower\nPML-related mortality and morbidity have been reported in patients who were\ninitially asymptomatic at diagnosis compared to patients who had\ncharacteristic clinical signs and symptoms at diagnosis.\n\nIf PML is confirmed, treatment with BRIUMVI should be discontinued.\n\nVaccinations: Administer all immunizations according to immunization\nguidelines: for live or live-attenuated vaccines, at least 4 weeks and,\nwhenever possible, at least 2 weeks prior to initiation of BRIUMVI for\nnon-live vaccines. BRIUMVI may interfere with the effectiveness of non-live\nvaccines. The safety of immunization with live or live-attenuated vaccines\nduring or following administration of BRIUMVI has not been studied.\nVaccination with live virus vaccines is not recommended during treatment and\nuntil B-cell repletion.\n\nVaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy:\nIn infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell\ncounts prior to administration of live or live-attenuated vaccines as measured\nby CD19(+) B-cells. Depletion of B-cells in these infants may increase the\nrisks from live or live-attenuated vaccines. Inactivated or non-live vaccines\nmay be administered prior to B-cell recovery. Assessment of vaccine immune\nresponses, including consultation with a qualified specialist, should be\nconsidered to determine whether a protective immune response was mounted.\n\nFetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm\nwhen administered to a pregnant woman. Transient peripheral B-cell depletion\nand lymphocytopenia have been reported in infants born to mothers exposed to\nother anti-CD20 B-cell depleting antibodies during pregnancy. Advise females\nof reproductive potential to use effective contraception during BRIUMVI\ntreatment and for 6 months after the last dose.\n\nReduction in Immunoglobulins: As expected with any B-cell depleting therapy,\ndecreased immunoglobulin levels were observed. Decrease in immunoglobulin M\n(IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the\npatients treated with teriflunomide in RMS clinical trials. Monitor the levels\nof quantitative serum immunoglobulins during treatment, especially in patients\nwith opportunistic or recurrent infections, and after discontinuation of\ntherapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a\npatient with low immunoglobulins develops a serious opportunistic infection or\nrecurrent infections, or if prolonged hypogammaglobulinemia requires treatment\nwith intravenous immunoglobulins.\n\nLiver Injury: Clinically significant liver injury, without findings of viral\nhepatitis, has been reported in the postmarketing setting in patients treated\nwith anti-CD20 B-cell depleting therapies approved for the treatment of MS,\nincluding BRIUMVI. Signs of liver injury, including markedly elevated serum\nhepatic enzymes with elevated total bilirubin, have occurred from weeks to\nmonths after administration.\n\nPatients treated with BRIUMVI found to have an alanine aminotransaminase (ALT)\nor aspartate aminotransferase (AST) greater than 3x the upper limit of normal\n(ULN) with serum total bilirubin greater than 2x ULN are potentially at risk\nfor severe drug-induced liver injury.\n\nObtain liver function tests prior to initiating treatment with BRIUMVI, and\nmonitor for signs and symptoms of any hepatic injury during treatment. Measure\nserum aminotransferases, alkaline phosphatase, and bilirubin levels promptly\nin patients who report symptoms that may indicate liver injury, including new\nor worsening fatigue, anorexia, nausea, vomiting, right upper abdominal\ndiscomfort, dark urine, or jaundice. If liver injury is present and an\nalternative etiology is not identified, discontinue BRIUMVI.\n\nMost Common Adverse Reactions: The most common adverse reactions in RMS trials\n(incidence of at least 10%) were infusion reactions and upper respiratory\ntract infections.\n\nPhysicians, pharmacists, or other healthcare professionals with questions\nabout BRIUMVI should visit www.briumvi.com.\n\nABOUT BRIUMVI PATIENT SUPPORT in the U.S. \nBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to\nsupport U.S. patients through their treatment journey in a way that works best\nfor them. More information about the BRIUMVI Patient Support program can be\naccessed at www.briumvipatientsupport.com.\n\nABOUT MULTIPLE SCLEROSIS \nRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the\ncentral nervous system (CNS) and includes people with relapsing-remitting\nmultiple sclerosis (RRMS) and people with secondary progressive multiple\nsclerosis (SPMS) who continue to experience relapses. RRMS is the most common\nform of multiple sclerosis (MS) and is characterized by episodes of new or\nworsening signs or symptoms (relapses) followed by periods of recovery. It is\nestimated that nearly 1 million people are living with MS in the United States\nand approximately 85% are initially diagnosed with RRMS.(1,2) The majority of\npeople who are diagnosed with RRMS will eventually transition to SPMS, in\nwhich they experience steadily worsening disability over time. Worldwide, more\nthan 2.3 million people have a diagnosis of MS.(1)\n\nABOUT TG THERAPEUTICS\nTG Therapeutics is a fully integrated, commercial stage, biotechnology company\nfocused on the acquisition, development and commercialization of novel\ntreatments for B-cell diseases. In addition to a research pipeline, TG\nTherapeutics has received approval from the U.S. Food and Drug Administration\n(FDA) for BRIUMVI(®) (ublituximab-xiiy) to treat adult patients with\nrelapsing forms of multiple sclerosis, including clinically isolated syndrome,\nrelapsing-remitting disease, and active secondary progressive disease, as well\nas approval from several regulatory agencies outside of the U.S. for BRIUMVI\nto treat adult patients with RMS who have active disease defined by clinical\nor imaging features. For more information, visit www.tgtherapeutics.com, and\nfollow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn\n(https://www.globenewswire.com/Tracker?data=XSsWzrLGnaYYRDT6U-4RkceGuqUnTGrbl_lYTO1CORb-a5klGNvgsnI4tfJVEnLiI7Pkf7Q2l9RrMcK-KbjWouHoFJKfBclXlCJAv3FwMEepZx-CVpi7P6zfxVWMbfhNukgSn9ajXfozDNHUQGZJWMSByOGL4RkZhH4833kObIm7V3kSTWdnwVHX_84TNXMehSsHwc3n1Edu6ZtDQ7z-BOy1kZJMZi_jc5O4HKu2GHa0y7eL3kY2v8EwdrCrleRt4Z7ecMUeMkFBldgNuO-NVy1x5s2qMlkZK2N5IoWjqB_RmGvI7IAoGW2_WmY__hkzqwluSMUkyqU89QBFzqfoMYB7dBueX8D3fJw3JGuey8efKCx-JQxv34lx8g1NDsw-viJ6-MMAGzwioV_KZEIDvOFB2_SyM5LbxYkNMe4oSe57cIqkXGjOpjsNgxz92LDS).\n\nBRIUMVI(®) is a registered trademark of TG Therapeutics, Inc.\n\nCautionary Statement\nThis press release contains forward-looking statements that involve a number\nof risks and uncertainties. For those statements, we claim the protection of\nthe safe harbor for forward-looking statements contained in the Private\nSecurities Litigation Reform Act of 1995.\n\nAny forward-looking statements in this press release are based on management's\ncurrent expectations and beliefs and are subject to a number of risks,\nuncertainties and important factors that may cause actual events or results to\ndiffer materially from those expressed or implied by any forward- looking\nstatements contained in this press release. In addition to the risk factors\nidentified from time to time in our reports filed with the U.S. Securities and\nExchange Commission (SEC), factors that could cause our actual results to\ndiffer materially include the below.\n\nSuch forward looking statements include but are not limited to statements\nregarding the ULTIMATE I & II Phase 3 studies, the ULTIMATE KIDS I & II\nstudies, the ENHANCE study, the ENABLE study and BRIUMVI as a treatment for\nrelapsing forms of multiple sclerosis (RMS). Additional factors that could\ncause our actual results to differ materially include the following: the risk\nthat the data from any studies evaluating BRIUMVI that we announce or publish\nmay change, or the product profile of BRIUMVI may be impacted, as more data or\nadditional endpoints are analyzed; the risk that data may emerge from future\nclinical studies or from adverse event reporting that may affect the safety\nand tolerability profile and commercial potential of BRIUMVI; the risk that\nany individual patient’s clinical experience in the post-marketing setting,\nor the aggregate patient experience in the post-marketing setting, may differ\nfrom that demonstrated in controlled clinical trials such as ULTIMATE I and\nII; the risk that BRIUMVI will not be commercially successful; our ability to\nexpand our commercial infrastructure, and successfully market and sell BRIUMVI\nin RMS; the Company’s reliance on third parties for manufacturing,\ndistribution and supply, and a range of other support functions for our\ncommercial and clinical products, including BRIUMVI, and the ability of the\nCompany and its manufacturers and suppliers to produce and deliver BRIUMVI to\nmeet the market demand for BRIUMVI; the failure to obtain and maintain\nrequisite regulatory approvals, including the risk that the Company fails to\nsatisfy post-approval regulatory requirements; the uncertainties inherent in\nresearch and development and general political, economic and business\nconditions. Further discussion about these and other risks and uncertainties\ncan be found in our Annual Report on Form 10-K for the fiscal year ended\nDecember 31, 2025 and in our other filings with the U.S. Securities and\nExchange Commission.\n\nAny forward-looking statements set forth in this press release speak only as\nof the date of this press release. We do not undertake to update any of these\nforward-looking statements to reflect events or circumstances that occur after\nthe date hereof. This press release and prior releases are available at\nwww.tgtherapeutics.com. The information found on our website is not\nincorporated by reference into this press release and is included for\nreference purposes only.\n\nCONTACT:\n\nInvestor Relations \nEmail: ir@tgtxinc.com\nTelephone: 1.877.575.TGTX (8489), Option 4\n\nMedia Relations \nEmail: media@tgtxinc.com \nTelephone: 1.877.575.TGTX (8489), Option 6\n\n(1.)( MS Prevalence. National Multiple Sclerosis Society website.\nhttps://www.nationalmssociety.org/About-the-Society/MS-Prevalence. )(Accessed\nOctober 26, 2020.)( 2.)( Multiple Sclerosis International Federation, 2013\nvia Data monitor p. 236.)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0e613f5f-8c22-4c63-a73b-c08cc0fbec64)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8mxst8","title":"TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2026 Annual Meeting","author":"Globe Newswire","ticker":"TGTX","created":"2026-04-22T11:30:00.593Z","tickers":["TGTX"],"exchange":"NASDAQ","article_body":"NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:\nTGTX), today announced the presentation of data highlighting BRIUMVI(®)\n(ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis\n(RMS), at the American Academy of Neurology 2026 annual meeting in Chicago.\nLinks to each presentation are included below.\n\nMichael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics\nstated, “We are excited to present new data at AAN 2026 further supporting\nthe differentiated profile of BRIUMVI for people living with relapsing\nmultiple sclerosis. The results from the ENABLE and ENHANCE studies continue\nto build on our growing body of evidence demonstrating the real-world\neffectiveness, safety, and tolerability of BRIUMVI, and provide insights into\noptimized dosing approaches for IV BRIUMVI, respectively. We look forward to\ncontinuing to expand the clinical and real-world data supporting BRIUMVI as an\nimportant treatment option in adults with RMS.”\n\nTG PRESENTATIONS:\n\nPoster Presentation Title: Real World Clinical Experience from ENABLE, the\nFirst Phase 4 Observational Study for Patients with Relapsing Multiple\nSclerosis Initiating Ublituximab\n(https://www.globenewswire.com/Tracker?data=oezN8BMeEzpL23fXi7hV6P-mmYfavhyCdK7tVAFpXZEdCvvpGBbX-DNVCdk7lXF9HyoO0R3ZKwOnL9vhzRK1-xHCItZVM8aDiSZF8s0inkhRhcRNh0uedxW9BeO5N3Qcuw2YCrVkXSd7Sfh2Xt3D0aa0OrmDJRdYpWsCKOZZqNkJsZEFbGw2jUlTUM95fyhqXxDRVFemHrXZNN44uzxGKzhNIbKjv7WILX6HpYne9IeyXfQHwRDC4CKEnEwuJTqjPFL5x7a7TCx-TVg1RngM7AXDmVYtLNfR4rN-fkX7DGu6jNqpkLlxhpSa8uyWpvob4HdsWiFUIHho1EqPcWXlLdhaZtMhpKO-EU6r9FEmoq0=)\n\nLead Author: Carrie Hersh, DO, MSc, FAAN - Cleveland Clinic Lou Ruvo Center\nfor Brain Health (CCLRCBH) (MS) & Neuroimmunology Specialist – Assoc.\nProfessor of Neurology at Cleveland Clinic Lerner College of Medicine of Case\nWestern Reserve University\n\nPoster Presentation Title: Safety and Tolerability of a Modified Ublituximab\nDosing Regimen: Updates from the ENHANCE Study\n(https://www.globenewswire.com/Tracker?data=EBkjUKAgMXHNONcNs39ePJGE2vcuXqFnafu71G_mfOyfCRPK3ocxOtBcdpdWEJbhwqHGWfGSwBstLyPHaRe6HYMqhfIPAfUKDLhPbKiuiydss26OpVcbMD_v1etj0tl9cgsNFW8XadB3gW_a2gtJp9H6kAVMboYcNS1YcgygJprDnovRyjdFTBiWhvxagxzpRyGqxQHamFFRBP69tBS3HB6rpT_ALOmLyqXAD0D8ETexOE-ZSS_-LuIS15OJ4Fk2mz_A3KlB6S3GvjYPKQd1DQ==)\n\nLead Author: Barry A. Singer, MD - Director, The MS Center for Innovations in\nCare - Missouri Baptist Medical Center, St. Louis, MO, United States\n\nThe above presentations are also available on the Publications page, located\nwithin the Pipeline section, of the Company’s website at\nwww.tgtherapeutics.com/publications/.\n\nABOUT BRIUMVI(®) (ublituximab-xiiy) 150 mg/6 mL Injection for IV\nBRIUMVI is a novel monoclonal antibody that targets a unique epitope on\nCD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven\nto be an important therapeutic approach for the management of autoimmune\ndisorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar\nmolecules normally expressed on the antibody. Removal of these sugar\nmolecules, a process called glycoengineering, allows for efficient B-cell\ndepletion at low doses. \n\nBRIUMVI is indicated in the U.S. for the treatment of adults with RMS,\nincluding clinically isolated syndrome, relapsing-remitting disease, and\nactive secondary progressive disease and in several countries outside of the\nU.S. for the treatment of adult patients with RMS with active disease defined\nby clinical or imaging features.\n\nA list of authorized specialty distributors can be found at www.briumvi.com.\n\nIMPORTANT SAFETY INFORMATION\nContraindications: BRIUMVI is contraindicated in patients with:\n* Active Hepatitis B Virus infection\n* A history of life-threatening infusion reaction to BRIUMVI\nWARNINGS AND PRECAUTIONS\n\nInfusion Reactions: BRIUMVI can cause infusion reactions, which can include\npyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat\nirritation, erythema, and an anaphylactic reaction. In MS clinical trials, the\nincidence of infusion reactions in BRIUMVI-treated patients who received\ninfusion reaction-limiting premedication prior to each infusion was 48%, with\nthe highest incidence within 24 hours of the first infusion. 0.6% of\nBRIUMVI-treated patients experienced infusion reactions that were serious,\nsome requiring hospitalization.\n\nObserve treated patients for infusion reactions during the infusion and for at\nleast one hour after the completion of the first two infusions unless infusion\nreaction and/or hypersensitivity has been observed in association with the\ncurrent or any prior infusion. Inform patients that infusion reactions can\noccur up to 24 hours after the infusion. Administer the recommended\npre-medication to reduce the frequency and severity of infusion reactions. If\nlife-threatening, stop the infusion immediately, permanently discontinue\nBRIUMVI, and administer appropriate supportive treatment. Less severe infusion\nreactions may involve temporarily stopping the infusion, reducing the infusion\nrate, and/or administering symptomatic treatment.\n\nInfections: Serious, life-threatening or fatal, bacterial and viral infections\nhave been reported in BRIUMVI-treated patients. In MS clinical trials, the\noverall rate of infections in BRIUMVI-treated patients was 56% compared to 54%\nin teriflunomide-treated patients. The rate of serious infections was 5%\ncompared to 3% respectively. There were 3 infection-related deaths in\nBRIUMVI-treated patients. The most common infections in BRIUMVI-treated\npatients included upper respiratory tract infection (45%) and urinary tract\ninfection (10%). Delay BRIUMVI administration in patients with an active\ninfection until the infection is resolved.\n\nConsider the potential for increased immunosuppressive effects when initiating\nBRIUMVI after immunosuppressive therapy or initiating an immunosuppressive\ntherapy after BRIUMVI.\n\nHepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS\npatient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic\nfailure, and death caused by HBV reactivation have occurred in patients\ntreated with anti-CD20 antibodies. Perform HBV screening in all patients\nbefore initiation of treatment with BRIUMVI. Do not start treatment with\nBRIUMVI in patients with active HBV confirmed by positive results for HB\nsurface antigen (HBsAg) and anti-HB tests. For patients who are negative for\nHBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV\n[HBsAg+], consult a liver disease expert before starting and during treatment.\n\nProgressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic\nviral infection of the brain caused by the JC virus (JCV) that typically only\noccurs in patients who are immunocompromised, and that usually leads to death\nor severe disability. JCV infection resulting in PML has been observed in\npatients treated with anti-CD20 antibodies, including BRIUMVI, and other MS\ntherapies.\n\nIf PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic\nevaluation. Typical symptoms associated with PML are diverse, progress over\ndays to weeks, and include progressive weakness on one side of the body or\nclumsiness of limbs, disturbance of vision, and changes in thinking, memory,\nand orientation leading to confusion and personality changes.\n\nMRI findings may be apparent before clinical signs or symptoms; monitoring for\nsigns consistent with PML may be useful. Further investigate suspicious\nfindings to allow for an early diagnosis of PML, if present. Following\ndiscontinuation of another MS medication associated with PML, lower\nPML-related mortality and morbidity have been reported in patients who were\ninitially asymptomatic at diagnosis compared to patients who had\ncharacteristic clinical signs and symptoms at diagnosis.\n\nIf PML is confirmed, treatment with BRIUMVI should be discontinued.\n\nVaccinations: Administer all immunizations according to immunization\nguidelines: for live or live-attenuated vaccines, at least 4 weeks and,\nwhenever possible, at least 2 weeks prior to initiation of BRIUMVI for\nnon-live vaccines. BRIUMVI may interfere with the effectiveness of non-live\nvaccines. The safety of immunization with live or live-attenuated vaccines\nduring or following administration of BRIUMVI has not been studied.\nVaccination with live virus vaccines is not recommended during treatment and\nuntil B-cell repletion.\n\nVaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy:\nIn infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell\ncounts prior to administration of live or live-attenuated vaccines as measured\nby CD19(+) B-cells. Depletion of B-cells in these infants may increase the\nrisks from live or live-attenuated vaccines. Inactivated or non-live vaccines\nmay be administered prior to B-cell recovery. Assessment of vaccine immune\nresponses, including consultation with a qualified specialist, should be\nconsidered to determine whether a protective immune response was mounted.\n\nFetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm\nwhen administered to a pregnant woman. Transient peripheral B-cell depletion\nand lymphocytopenia have been reported in infants born to mothers exposed to\nother anti-CD20 B-cell depleting antibodies during pregnancy. Advise females\nof reproductive potential to use effective contraception during BRIUMVI\ntreatment and for 6 months after the last dose.\n\nReduction in Immunoglobulins: As expected with any B-cell depleting therapy,\ndecreased immunoglobulin levels were observed. Decrease in immunoglobulin M\n(IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the\npatients treated with teriflunomide in RMS clinical trials. Monitor the levels\nof quantitative serum immunoglobulins during treatment, especially in patients\nwith opportunistic or recurrent infections, and after discontinuation of\ntherapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a\npatient with low immunoglobulins develops a serious opportunistic infection or\nrecurrent infections, or if prolonged hypogammaglobulinemia requires treatment\nwith intravenous immunoglobulins.\n\nLiver Injury: Clinically significant liver injury, without findings of viral\nhepatitis, has been reported in the postmarketing setting in patients treated\nwith anti-CD20 B-cell depleting therapies approved for the treatment of MS,\nincluding BRIUMVI. Signs of liver injury, including markedly elevated serum\nhepatic enzymes with elevated total bilirubin, have occurred from weeks to\nmonths after administration.\n\nPatients treated with BRIUMVI found to have an alanine aminotransaminase (ALT)\nor aspartate aminotransferase (AST) greater than 3x the upper limit of normal\n(ULN) with serum total bilirubin greater than 2x ULN are potentially at risk\nfor severe drug-induced liver injury.\n\nObtain liver function tests prior to initiating treatment with BRIUMVI, and\nmonitor for signs and symptoms of any hepatic injury during treatment. Measure\nserum aminotransferases, alkaline phosphatase, and bilirubin levels promptly\nin patients who report symptoms that may indicate liver injury, including new\nor worsening fatigue, anorexia, nausea, vomiting, right upper abdominal\ndiscomfort, dark urine, or jaundice. If liver injury is present and an\nalternative etiology is not identified, discontinue BRIUMVI.\n\nMost Common Adverse Reactions: The most common adverse reactions in RMS trials\n(incidence of at least 10%) were infusion reactions and upper respiratory\ntract infections.\n\nPhysicians, pharmacists, or other healthcare professionals with questions\nabout BRIUMVI should visit www.briumvi.com.\n\nABOUT BRIUMVI PATIENT SUPPORT in the U.S. \nBRIUMVI Patient Support is a flexible program designed by TG Therapeutics to\nsupport U.S. patients through their treatment journey in a way that works best\nfor them. More information about the BRIUMVI Patient Support program can be\naccessed at www.briumvipatientsupport.com.\n\nABOUT MULTIPLE SCLEROSIS \nRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the\ncentral nervous system (CNS) and includes people with relapsing-remitting\nmultiple sclerosis (RRMS) and people with secondary progressive multiple\nsclerosis (SPMS) who continue to experience relapses. RRMS is the most common\nform of multiple sclerosis (MS) and is characterized by episodes of new or\nworsening signs or symptoms (relapses) followed by periods of recovery. It is\nestimated that nearly 1 million people are living with MS in the United States\nand approximately 85% are initially diagnosed with RRMS.(1,2) The majority of\npeople who are diagnosed with RRMS will eventually transition to SPMS, in\nwhich they experience steadily worsening disability over time. Worldwide, more\nthan 2.3 million people have a diagnosis of MS.(1)\n\nABOUT TG THERAPEUTICS\nTG Therapeutics is a fully integrated, commercial stage, biotechnology company\nfocused on the acquisition, development and commercialization of novel\ntreatments for B-cell diseases. In addition to a research pipeline, TG\nTherapeutics has received approval from the U.S. Food and Drug Administration\n(FDA) for BRIUMVI(®) (ublituximab-xiiy) to treat adult patients with\nrelapsing forms of multiple sclerosis, including clinically isolated syndrome,\nrelapsing-remitting disease, and active secondary progressive disease, as well\nas approval from several regulatory agencies outside of the U.S. for BRIUMVI\nto treat adult patients with RMS who have active disease defined by clinical\nor imaging features. For more information, visit www.tgtherapeutics.com, and\nfollow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn\n(https://www.globenewswire.com/Tracker?data=XSsWzrLGnaYYRDT6U-4RkceGuqUnTGrbl_lYTO1CORb-a5klGNvgsnI4tfJVEnLiI7Pkf7Q2l9RrMcK-KbjWouHoFJKfBclXlCJAv3FwMEepZx-CVpi7P6zfxVWMbfhNukgSn9ajXfozDNHUQGZJWMSByOGL4RkZhH4833kObIm7V3kSTWdnwVHX_84TNXMehSsHwc3n1Edu6ZtDQ7z-BOy1kZJMZi_jc5O4HKu2GHa0y7eL3kY2v8EwdrCrleRt4Z7ecMUeMkFBldgNuO-NVy1x5s2qMlkZK2N5IoWjqB_RmGvI7IAoGW2_WmY__hkzqwluSMUkyqU89QBFzqfoMYB7dBueX8D3fJw3JGuey8efKCx-JQxv34lx8g1NDsw-viJ6-MMAGzwioV_KZEIDvOFB2_SyM5LbxYkNMe4oSe57cIqkXGjOpjsNgxz92LDS).\n\nBRIUMVI(®) is a registered trademark of TG Therapeutics, Inc.\n\nCautionary Statement\nThis press release contains forward-looking statements that involve a number\nof risks and uncertainties. For those statements, we claim the protection of\nthe safe harbor for forward-looking statements contained in the Private\nSecurities Litigation Reform Act of 1995.\n\nAny forward-looking statements in this press release are based on management's\ncurrent expectations and beliefs and are subject to a number of risks,\nuncertainties and important factors that may cause actual events or results to\ndiffer materially from those expressed or implied by any forward- looking\nstatements contained in this press release. In addition to the risk factors\nidentified from time to time in our reports filed with the U.S. Securities and\nExchange Commission (SEC), factors that could cause our actual results to\ndiffer materially include the below.\n\nSuch forward looking statements include but are not limited to statements\nregarding the ULTIMATE I & II Phase 3 studies, the ULTIMATE KIDS I & II\nstudies, the ENHANCE study, the ENABLE study and BRIUMVI as a treatment for\nrelapsing forms of multiple sclerosis (RMS). Additional factors that could\ncause our actual results to differ materially include the following: the risk\nthat the data from any studies evaluating BRIUMVI that we announce or publish\nmay change, or the product profile of BRIUMVI may be impacted, as more data or\nadditional endpoints are analyzed; the risk that data may emerge from future\nclinical studies or from adverse event reporting that may affect the safety\nand tolerability profile and commercial potential of BRIUMVI; the risk that\nany individual patient’s clinical experience in the post-marketing setting,\nor the aggregate patient experience in the post-marketing setting, may differ\nfrom that demonstrated in controlled clinical trials such as ULTIMATE I and\nII; the risk that BRIUMVI will not be commercially successful; our ability to\nexpand our commercial infrastructure, and successfully market and sell BRIUMVI\nin RMS; the Company’s reliance on third parties for manufacturing,\ndistribution and supply, and a range of other support functions for our\ncommercial and clinical products, including BRIUMVI, and the ability of the\nCompany and its manufacturers and suppliers to produce and deliver BRIUMVI to\nmeet the market demand for BRIUMVI; the failure to obtain and maintain\nrequisite regulatory approvals, including the risk that the Company fails to\nsatisfy post-approval regulatory requirements; the uncertainties inherent in\nresearch and development and general political, economic and business\nconditions. Further discussion about these and other risks and uncertainties\ncan be found in our Annual Report on Form 10-K for the fiscal year ended\nDecember 31, 2025 and in our other filings with the U.S. Securities and\nExchange Commission.\n\nAny forward-looking statements set forth in this press release speak only as\nof the date of this press release. We do not undertake to update any of these\nforward-looking statements to reflect events or circumstances that occur after\nthe date hereof. This press release and prior releases are available at\nwww.tgtherapeutics.com. The information found on our website is not\nincorporated by reference into this press release and is included for\nreference purposes only.\n\nCONTACT:\n\nInvestor Relations \nEmail: ir@tgtxinc.com\nTelephone: 1.877.575.TGTX (8489), Option 4\n\nMedia Relations \nEmail: media@tgtxinc.com \nTelephone: 1.877.575.TGTX (8489), Option 6\n\n(1.)( MS Prevalence. National Multiple Sclerosis Society website.\nhttps://www.nationalmssociety.org/About-the-Society/MS-Prevalence. )(Accessed\nOctober 26, 2020.)( 2.)( Multiple Sclerosis International Federation, 2013\nvia Data monitor p. 236.)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0e613f5f-8c22-4c63-a73b-c08cc0fbec64)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-04-22T11:30:00.649486114Z","server_sent_at_ms":1776857400649},"received_at":"2026-04-22T11:30:00.703Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}