TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment
TG Therapeutics (NASDAQ: TGTX) has initiated enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI for relapsing multiple sclerosis (RMS). The trial aims to develop a self-administered version of BRIUMVI, which is currently approved as an intravenous (IV) infusion.
The study will compare two subcutaneous dosing regimens (every 8 weeks and every 12 weeks) against the current IV format. If successful, BRIUMVI would become the only anti-CD20 therapy offering both IV and subcutaneous options, potentially accessing an additional 40% of the RMS CD20 market that prefers self-injectable treatments. The company anticipates potential approval by 2028.
TG Therapeutics (NASDAQ: TGTX) ha avviato l'arruolamento in uno studio di Fase 3 che valuta la somministrazione sottocutanea di BRIUMVI per la sclerosi multipla recidivante (RMS). L'obiettivo è sviluppare una versione autoiniettabile di BRIUMVI, attualmente approvata come infusione endovenosa (IV).
Lo studio confronterà due regimi sottocutanei (ogni 8 settimane e ogni 12 settimane) con l'attuale formulazione IV. In caso di esito positivo, BRIUMVI diventerebbe l'unica terapia anti-CD20 disponibile sia in versione IV sia sottocutanea, potenzialmente conquistando un ulteriore 40% del mercato CD20 per RMS che preferisce trattamenti autoiniettabili. L'azienda prevede una possibile approvazione entro il 2028.
TG Therapeutics (NASDAQ: TGTX) ha iniciado la inclusión de pacientes en un ensayo de Fase 3 que evalúa BRIUMVI subcutáneo para esclerosis múltiple recurrente (RMS). El estudio busca desarrollar una versión autoinyectable de BRIUMVI, actualmente aprobada como infusión intravenosa (IV).
El ensayo comparará dos regímenes subcutáneos (cada 8 semanas y cada 12 semanas) frente a la formulación IV actual. Si tiene éxito, BRIUMVI se convertiría en la única terapia anti-CD20 que ofrece opciones IV y subcutáneas, pudiendo acceder potencialmente a un 40% adicional del mercado CD20 para RMS que prefiere tratamientos autoadministrados. La compañía anticipa una posible aprobación para 2028.
TG Therapeutics (NASDAQ: TGTX)가 재발성 다발성경화증(RMS) 치료를 위한 피하주사형 BRIUMVI의 임상 3상 등록을 시작했습니다. 이 연구는 현재 정맥주사(IV)로 승인된 BRIUMVI의 자가주사형 버전을 개발하는 것을 목표로 합니다.
연구는 두 가지 피하 투여 간격(8주 간격 및 12주 간격)을 현재의 IV 제형과 비교합니다. 성공할 경우 BRIUMVI는 IV와 피하주사 옵션을 모두 제공하는 유일한 항-CD20 치료제가 되어, 자가주사 치료를 선호하는 RMS CD20 시장의 추가 40%에 접근할 수 있게 됩니다. 회사는 2028년까지 승인 가능성을 예상하고 있습니다.
TG Therapeutics (NASDAQ: TGTX) a lancé le recrutement d'une étude de phase 3 évaluant BRIUMVI en administration sous-cutanée pour la sclérose en plaques récurrente (RMS). L'essai vise à développer une version auto-administrable de BRIUMVI, actuellement approuvée en perfusion intraveineuse (IV).
L'étude comparera deux schémas posologiques sous-cutanés (toutes les 8 semaines et toutes les 12 semaines) au format IV actuel. En cas de succès, BRIUMVI deviendrait la seule thérapie anti-CD20 offrant à la fois des options IV et sous-cutanées, pouvant potentiellement capter un 40 % supplémentaire du marché CD20 pour la RMS préférant les traitements auto-injectables. La société anticipe une possible approbation d'ici 2028.
TG Therapeutics (NASDAQ: TGTX) hat mit der Rekrutierung für eine Phase-3-Studie begonnen, die subkutanes BRIUMVI bei schubförmig-remittierender Multipler Sklerose (RMS) untersucht. Ziel ist die Entwicklung einer zur Selbstinjektion geeigneten Version von BRIUMVI, das derzeit als intravenöse (IV) Infusion zugelassen ist.
Die Studie wird zwei subkutane Dosierungsschemata (alle 8 Wochen und alle 12 Wochen) mit dem aktuellen IV-Format vergleichen. Gelingt dies, wäre BRIUMVI die einzige Anti-CD20-Therapie, die sowohl IV- als auch subkutane Optionen bietet, und könnte potenziell zusätzliche 40 % des CD20-Marktes für RMS erschließen, der selbstinjektable Behandlungen bevorzugt. Das Unternehmen rechnet mit einer möglichen Zulassung bis 2028.
- Potential to capture 40% additional market share in RMS CD20 market
- Would be the only anti-CD20 therapy offering both IV and self-administered options
- Could provide greater treatment flexibility and choice for MS patients
- Long timeline to potential approval (2028)
- Success of the trial not guaranteed
- Will face competition from existing self-injectable MS treatments
Insights
TG Therapeutics advances subcutaneous BRIUMVI development, potentially expanding MS market reach by 40% with self-administered option by 2028.
TG Therapeutics has commenced patient enrollment in a crucial Phase 3 trial evaluating subcutaneous formulations of BRIUMVI (ublituximab-xiiy) for relapsing multiple sclerosis (RMS). This represents a significant strategic expansion of their MS platform beyond the currently approved intravenous (IV) version.
The trial design is methodologically sound, structured as a non-inferiority study comparing two subcutaneous dosing schedules (every 8 weeks and every 12 weeks) against the established IV formulation. The primary endpoint appropriately focuses on pharmacokinetic non-inferiority through area under the curve (AUC) measurements at week 24, which is the standard regulatory pathway for alternative administration routes of approved biologics.
What makes this development particularly compelling is the potential market expansion. Management estimates that approximately 40% of RMS patients in the CD20 market currently prefer self-injectable options. BRIUMVI would become the only anti-CD20 therapy offering both healthcare provider-administered (IV) and self-administered (subcutaneous) options, potentially addressing previously untapped patient segments.
The projected timeline targeting potential approval by 2028 aligns with typical regulatory pathways for supplemental applications. This development program significantly enhances BRIUMVI's competitive positioning in the anti-CD20 space by addressing patient convenience preferences – a critical factor in chronic disease markets where treatment adherence directly impacts outcomes. This could translate to expanded market share in a valuable therapeutic category, though the extended timeline means revenue impact remains several years away.
Phase 3 trial to evaluate two subcutaneous BRIUMVI dosing regimens
NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as several ex-US territories, as a one-hour intravenous (IV) infusion administered twice a year, following the starting dose, in adults with RMS.
Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “We are very pleased to announce the commencement of patient enrollment in our Phase 3 trial of subcutaneous BRIUMVI. This marks an important milestone for TG in our subcutaneous development program. If successful, BRIUMVI would be the only anti-CD20 therapy to offer an IV healthcare provider administered option, as well as an at home subcutaneous self-administered option, providing greater flexibility and choice. This program has the potential to significantly broaden the market opportunity for BRIUMVI, enabling us to reach the estimated
This is a Phase 3, non-inferiority, randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous BRIUMVI compared to IV BRIUMVI in adult participants with RMS. Participants will be randomized into one of three arms: an every 8 week regimen of subcutaneous BRIUMVI, an every 12 week regimen of subcutaneous BRIUMVI or the currently approved IV BRIUMVI dosing schedule. The primary endpoint of the trial is non inferior exposure of subcutaneous BRIUMVI compared to IV BRIUMVI with respect to area under the curve (AUC) at week 24.
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 the EU and UK for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in
Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.
Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.
Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here Briumvi | European Medicines Agency (europa.eu).
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) in Europe, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, Swissmedic in Switzerland, and Australia’s Therapeutic Goods Administration (TGA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding expectations for the timing and success of the commercialization and availability of BRIUMVI® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; expectations and timing for our subcutaneous BRIUMVI program, including feasibility, approvability and commercial acceptance, expectations and timing for our ENHANCE Phase 3 trial combining day 1 and day 15 doses, including, feasibility, approvability and commercial acceptance and impact on BRIUMVI sales, and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; ; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2025 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) commencing and completing a pivotal program for subcutaneous ublituximab, (ii) completing a pivotal program based on data from the ENHANCE trial to consolidate day 1 and day 15 dosing, (iii) enrolling patients into a trial evaluating BRIUMVI in MG, or (iv) enrolling patients into a trial evaluating azer-cel; the risk that the subcutaneous Phase 3 program will not be successful or if successful still will not be approved by the FDA or achieve commercial acceptance; the risk that the ENHANCE Phase 3 trial will not be successful or if successful will not be approved by the FDA or achieve commercial acceptance; the risk that we will not move forward with the development of BRIUMVI in MG and Azer-Cel following these preliminary studies; the uncertainties generally inherent in research and development; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the SEC.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
FAQ
What is the purpose of TG Therapeutics' new Phase 3 trial for BRIUMVI?
When does TGTX expect potential approval for subcutaneous BRIUMVI?
How could subcutaneous BRIUMVI impact TG Therapeutics' market opportunity?
What are the different dosing arms in the TGTX Phase 3 BRIUMVI trial?
What is the primary endpoint of TG Therapeutics' Phase 3 BRIUMVI trial?
