TG Therapeutics Announces Initiation of Phase 2 Trial Evaluating BRIUMVI in Patients with Treatment-Resistant Schizophrenia
Rhea-AI Summary
TG Therapeutics (NASDAQ:TGTX) has started a Phase 2, open-label, single-arm, multicenter trial of BRIUMVI (ublituximab-xiiy) in about 60 adults with treatment-resistant schizophrenia.
Participants receive intravenous BRIUMVI plus standard antipsychotics. The primary endpoint is ≥20% PANSS total score reduction at Week 12.
Positive
- Initiation of Phase 2 trial of BRIUMVI in treatment-resistant schizophrenia (~60 adults, ages 18–60)
- Study keeps patients on background standard-of-care antipsychotic therapy while adding BRIUMVI
- Clear primary endpoint: proportion achieving ≥20% PANSS total score reduction at Week 12
- Company highlights potential to expand BRIUMVI use into an unmet treatment-resistant schizophrenia population
Negative
- None.
News Market Reaction – TGTX
In the Jul 6 session, TGTX gained 4.05%, reflecting a moderate positive market reaction. Argus tracked a peak move of +5.5% during that session. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 09 | Phase 1 MG data | Positive | +5.4% | Positive Phase 1 MG data and start of potentially registration-directed Phase 2 trial. |
| Jun 03 | Subcutaneous MS data | Positive | +9.5% | Positive Phase 1 results for high-concentration subcutaneous BRIUMVI in multiple sclerosis. |
| Jun 01 | Post-hoc MS data | Positive | -1.4% | Post-hoc Phase 3 MS data showing strong efficacy versus teriflunomide over 96 weeks. |
| May 27 | Phase 3 ENHANCE data | Positive | -1.3% | Phase 3b ENHANCE trial met primary endpoint with single 600 mg infusion regimen. |
| Apr 15 | Phase 3 enrollment | Positive | +0.1% | Completion of enrollment for Phase 3 trial evaluating subcutaneous BRIUMVI in MS. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial updates for BRIUMVI have often been positive but have produced mixed share reactions, with both rallies and pullbacks following similar announcements.
Key Terms
phase 2 clinical
open-label clinical
single-arm clinical
panss clinical
standard-of-care medical
antipsychotic medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Phase 2 trial to evaluate the effects of B-cell depletion with BRIUMVI in approximately 60 patients with treatment-resistant schizophrenia based on emerging evidence linking immune dysfunction to disease in a subset of patients
NEW YORK, July 06, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI® (ublituximab-xiiy), in adults with treatment-resistant schizophrenia.
The Phase 2 study is an open-label trial designed to evaluate the efficacy and safety of BRIUMVI in approximately 60 adults with schizophrenia who continue to experience significant symptoms despite receiving standard-of-care antipsychotic treatment.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “The initiation of this Phase 2 study represents an exciting step in exploring the potential role of B-cell depletion in schizophrenia. There is emerging scientific evidence suggesting that immune system dysfunction and neuroinflammation may play a role in the pathophysiology of schizophrenia in a subset of patients. This scientific rationale is further supported by encouraging preliminary clinical findings with rituximab in a small cohort of patients with treatment-resistant schizophrenia, supporting further investigation of B-cell depletion in this condition. Given BRIUMVI’s demonstrated ability to rapidly and efficiently deplete B cells and its established safety profile, we believe it is a compelling candidate to explore in this setting. This study is designed to determine whether B-cell depletion with BRIUMVI can improve symptoms in patients with treatment-resistant schizophrenia and, if successful, could expand the potential utility of BRIUMVI into a significant area of unmet medical need. We look forward to sharing results as they become available.”
OVERVIEW OF THE PHASE 2 SCHIZOPHRENIA STUDY
The Phase 2 study is an open-label, single-arm, multicenter trial evaluating the efficacy and safety of BRIUMVI (ublituximab-xiiy) in adults with treatment-resistant schizophrenia. Approximately 60 participants between the ages of 18 and 60 years are expected to be enrolled.
Participants will receive intravenous BRIUMVI and remain on background standard-of-care antipsychotic therapy throughout the study. The primary endpoint is the proportion of participants achieving at least a
ABOUT SCHIZOPHRENIA
Schizophrenia is a chronic and severe psychiatric disorder characterized by disruptions in thought, perception, emotion, and behavior. Symptoms may include hallucinations, delusions, disorganized thinking, and cognitive impairment, often resulting in significant functional disability. While available antipsychotic therapies can help manage symptoms, many patients continue to experience persistent symptoms despite treatment, highlighting the need for new therapeutic approaches. Emerging research has suggested a potential role for immune dysregulation and neuroinflammatory pathways in the pathophysiology of schizophrenia in some patients, though the clinical relevance of these findings remains under investigation.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in
Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.
Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.
Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here: Briumvi | European Medicines Agency (europa.eu).
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding our plans, business strategies and operations related to the commercialization of BRIUMVI® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) completing a pivotal program for subcutaneous ublituximab, (ii) enrolling patients into a trial evaluating BRIUMVI in MG or schizophrenia, or (iii) enrolling patients into a trial evaluating azer-cel; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the risk that we will not move forward with the development of BRIUMVI in MG, schizophrenia and Azer-Cel following these preliminary studies; the uncertainties generally inherent in research and development, including the risk that the data from Phase 1 studies, including safety and efficacy, may not be replicated in registration directed or Phase 3 studies conducted in larger populations with longer follow-up; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the SEC.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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
