Briumvi (ublituximab-xiiy) / LFB SA, Ildong, TG Therap, Neuraxpharm - LARVOL DELTA

PROVIDE: A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk (clinicaltrials.gov) - P=N/A | N=16 | Active, not recruiting | Sponsor: TG Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

Anti-CD20 monoclonal antibody therapies in relapsing multiple sclerosis: A systematic review and meta-analysis of randomised controlled trials. (PubMed, Mult Scler Relat Disord) - "Anti-CD20 mAbs confer consistent, clinically meaningful reductions in relapse rate and MRI disease activity. In the only direct head-to-head RCT, rituximab was non-inferior to ocrelizumab for MRI disease activity in newly diagnosed relapsing MS. Heterogeneity for MRI outcomes is strongly associated with trial design and warrants cautious interpretation; with few trials per stratum this attribution is associative rather than definitive. These agents represent a high-efficacy treatment class for relapsing MS."

Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

An Open-Label Phase II Feasibility Study for the Use of Ublituximab in Adults With Down Syndrome Regression Disorder (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Jonathan Santoro

New P2 trial • CNS Disorders • Developmental Disorders • Genetic Disorders • Mental Retardation • Psychiatry

Long-term efficacy and safety of ublituximab in the treatment of multiple sclerosis: A critical review of medical literature. (PubMed, Mult Scler Relat Disord) - "UTX represents a potent, efficient disease-modifying therapy for relapsing MS with robust, durable efficacy comparable to other anti-CD20 agents. Its primary clinical advantage is the streamlined one-hour maintenance infusion every 24 weeks. While the absence of head-to-head trials against other high-efficacy agents and knowledge gaps regarding long-term safety in diverse populations remain limitations, current evidence supports ublituximab's position in aggressive early-treatment strategies, provided that clinical vigilance for cumulative risks such as hypogammaglobulinemia is maintained. Future research should prioritize comparative trials, investigation in progressive MS phenotypes, and validation of optimized dosing strategies."

Journal • Review • CNS Disorders • Infectious Disease • Multiple Sclerosis

ENHANCE: Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: TG Therapeutics, Inc. | Trial completion date: Dec 2027 ➔ Jan 2027 | Trial primary completion date: Dec 2027 ➔ Jan 2027

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Persistent B-cell depletion after ublituximab for multiple sclerosis. (PubMed, J Neurol) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

Positive Topline Phase 3 ENHANCE Data (GlobeNewswire) - "The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion."

P3 data: top line • Immunology • Multiple Sclerosis

BRIUMVI in Myasthenia Gravis (GlobeNewswire) - "Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG."

Trial status • Immunology • Myasthenia Gravis

TG Therapeutics Reports Second Quarter 2026 Financial Results and Raises BRIUMVI Revenue Guidance (GlobeNewswire) - "BRIUMVI U.S. net product revenue of $227.7 million for the second quarter 2026, representing approximately a 64% increase over the same period last year; Total global revenue of $240.3 million for the second quarter 2026."

Sales • Immunology • Multiple Sclerosis

Infusion-related reactions and premedication patterns in ublituximab-treated multiple sclerosis patients: a multicenter real-world study. (PubMed, Front Neurol) - "No independent predictors of IRRs were identified. Importantly, all IRRs observed in this study were mild to moderate, suggesting that ublituximab infusions were generally well tolerated in this real-world cohort."

Journal • Real-world evidence • CNS Disorders • Multiple Sclerosis

Optimizing Infusion Center Efficiency in Multiple Sclerosis: A Nursing Multicenter Survey on Organizational Impact of Ublituximab. (PubMed, Healthcare (Basel)) - "Nurses identified several opportunities to improve infusion pathways and suggested that shorter infusion protocols may support organizational optimization. However, these potential advantages should be regarded as hypotheses based on nurses' perceptions and require confirmation in prospective comparative studies."

Journal • CNS Disorders • Multiple Sclerosis

Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: TG Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

PROVIDE: A Study Evaluating the Presence and Concentration of BRIUMVI (Ublituximab) in Breast Milk (clinicaltrials.gov) - P=N/A | N=16 | Recruiting | Sponsor: TG Therapeutics, Inc. | Trial completion date: Jun 2026 ➔ Oct 2026 | Trial primary completion date: Jun 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Anti-CD20 Therapies in Pediatric Acquired Demyelinating Syndromes: Evidence Across MS, AQP4-IgG-Positive NMOSD and MOGAD. (PubMed, CNS Drugs) - "Ocrelizumab has the most advanced pediatric evidence among approved anti-CD20 agents, including dose-selection data from OPERETTA I and comparative Phase 3 data from OPERETTA II, where it reduced MRI activity compared with fingolimod and showed sustained B-cell depletion...Upcoming trials of ofatumumab, ublituximab, and rituximab-based strategies in MOGAD will be critical to refine pediatric dosing, define biomarkers of treatment durability, and establish age-specific safety surveillance for the developing immune system. This review summarizes knowledge on B-cell maturation in early life and anti-CD20 treatment outcomes in pediatric patients with these conditions. Safety and tolerability considerations, optimal timing of therapy, and remaining gaps in evidence are also explored, highlighting the need for age-specific biomarkers and prospective studies to better define individualized treatment strategies and to clarify long-term consequences of B-cell-depleting therapies..."

Journal • Review • CNS Disorders • Hematological Disorders • Infectious Disease • Leukopenia • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Neutropenia • Pediatrics • Rare Diseases • Solid Tumor

NET-MS: No Evidence Of Disease Activity After Autologous Haematopoietic Stem Cell Transplantation In Aggressive Multiple Sclerosis (clinicaltrialsregister.eu) - P1/2 | N=90 | Completed | Sponsor: Fondazione Italiana Sclerosi Multipla Ente Del Terzo Settore/et S | Recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis • Transplantation

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CCND1 • CD20

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - P2/3 | N=240 | Recruiting | Sponsor: TG Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis • Pediatrics

TG Therapeutics Announces Initiation of Phase 2 Trial Evaluating BRIUMVI in Patients with Treatment-Resistant Schizophrenia (GlobeNewswire) - "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."

Trial status • Schizophrenia

Ublituximab for relapsing forms of MS: interim results on real-world treatment satisfaction, quality of life and tolerability from the BRILL study (EAN 2026) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence

Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: TG Therapeutics, Inc.

New P2 trial • CNS Disorders • Psychiatry • Schizophrenia

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: TG Therapeutics, Inc.

New P2 trial • CNS Disorders • Myasthenia Gravis

Real-world use of Ublituximab: Patient profile in clinical practice (EAN 2026) - No abstract available

Clinical • Real-world • Real-world evidence

Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis. (PubMed, Front Immunol) - P3 | "To evaluate the efficacy of ublituximab versus teriflunomide in participants without prior DMT (treatment-naïve population) and in a subset of treatment-naïve participants with symptom onset ≤ three years (early treatment subpopulation). Ublituximab was associated with significant treatment benefits at Week 96 in treatment-naïve participants and those receiving treatment within three years of symptom onset. https://clinicaltrials.gov/study/NCT03277261 and https://clinicaltrials.gov/study/NCT03277248, identifiers NCT03277261 and NCT03277248."

Clinical • Journal • P3 data • CNS Disorders • Multiple Sclerosis

Update on the Randomized BEAT-MS Trial Comparing Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (CMSC 2026) - "In the AHSCT arm, peripheral blood stem cells (PBSC) are mobilized with cyclophosphamide, dexamethasone, and filgrastim, collected by leukapheresis, and cryopreserved. Participants receive conditioning with carmustine, etoposide, cytarabine, melphalan (BEAM) and rabbit anti-thymocyte globulin prior to infusion of the unmanipulated autologous PBSC. In the BAT arm, participants are treated with any of the following: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab or rituximab... BEAT-MS is a large prospective multi-center randomized clinical trial comparing AHSCT to contemporary high efficacy DMTs, with the goal of determining whether AHSCT is a clinically effective, safe, and cost-effective treatment option for highly active RMS."

Clinical • CNS Disorders • Immunology • Multiple Sclerosis

Real-World Study of Ocrelizumab and Other Disease-Modifying Therapy Utilization and Disease Activity from Preconception through Postpartum in Women With MS (CMSC 2026) - "Among WwMS with preconception DMT use, lower-efficacy DMTs (LE-DMTs) (interferons, glatiramer acetate; 28%) and ocrelizumab (OCR; 26%) were the most common, followed by fumarates (15%), natalizumab (12%), sphingosine-1-phosphate (S1P) modulators (10%), other anti-CD20s (ofatumumab, ublituximab, off-label rituximab; 5%), other DMTs (teriflunomide, alemtuzumab, cladribine; 4%). Almost half of WwMS remained untreated from preconception through postpartum. OCR was the most frequently used DMT postpartum, with limited administrations during pregnancy. This trend may reflect growing confidence in OCR safety and efficacy, with recent evidence supporting use during pregnancy planning, while allowing for an administration-free pregnancy."

Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis