TG Therapeutics

The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.Show more

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.

The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).Show more

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.Show more

The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.Show more

TG Therapeutics is a biotechnology company built around a single antibody, ublituximab, that it has been developing since 2012. The company took shape when a small private startup holding a license to the antibody merged into a public shell, Manhattan Pharmaceuticals, and took the TG Therapeutics name that year under founder and CEO Michael Weiss. For most of its first decade TG was a cancer company, and that chapter ended badly: in 2022 it withdrew its approved lymphoma pill Ukoniq (umbralisib) from the market and pulled a pending application in chronic lymphocytic leukemia after a large trial showed a survival imbalance. TG then bet everything on multiple sclerosis, moved its headquarters from New York to Morrisville, North Carolina, and today trades on Nasdaq under the ticker TGTX.

The bet paid off. BRIUMVI (ublituximab-xiiy) was approved by the FDA on December 28, 2022 for relapsing forms of multiple sclerosis. It works by depleting B cells, the immune cells that drive much of the inflammation in MS, through a marker on their surface called CD20, and its main practical advantage over older B cell therapies is speed: after the first two starter doses, maintenance treatment is a one-hour infusion every six months. Sales have grown quickly, reaching $594 million in the U.S. in 2025, and TG expects roughly $890 to $905 million in 2026. Neuraxpharm sells the drug in Europe, where it was approved in June 2023. In May 2026 the Phase 3 ENHANCE study showed that a single 600mg infusion on day one delivers the same drug exposure as the current two-step start, and a Phase 3 trial of a subcutaneous injection version, designed for dosing every two or three months, is fully enrolled with results expected around the end of 2026 or early 2027. A Phase 2/3 study in children ages 10 to 17 with relapsing MS began in July 2026.

For the rare disease community, the program to watch is myasthenia gravis. In June 2026 TG reported that 9 of 11 patients with anti-AChR antibody-positive myasthenia gravis in an early study of subcutaneous BRIUMVI reached a clinically meaningful improvement in daily-living symptoms at 24 weeks, and in July 2026 it started a randomized, placebo-controlled Phase 2 trial (NCT07673744) that the company describes as potentially registration-directed. The design is unusual: every patient first receives a round of efgartigimod, an approved FcRn blocker that lowers antibody levels quickly, and those who respond are then randomized to BRIUMVI or placebo to see which group stays well longer. Results are expected in 2028. TG is also testing BRIUMVI in treatment-resistant schizophrenia and, through a license with Precision BioSciences, an off-the-shelf CD19 CAR-T cell therapy called azer-cel in progressive multiple sclerosis and other B cell autoimmune diseases, with the first data expected in the second half of 2026.

TG Therapeutics has 1 FDA-approved drug with a rare disease use that we track, as of October 2026.

Briumvi (ublituximab), approved 2022: Multiple Sclerosis.

Source: the FDA's openFDA label database, matched to the rare diseases on Trial Friend; the list updates automatically and can include older products.

Yes, for 1 of its FDA-approved rare disease medicine that we track, each checked on TG Therapeutics' own website.

Briumvi: BRIUMVI Patient Support (TG Therapeutics), 1-833-274-8684. Offers copay help with private insurance and insurance help. Checked October 19, 2026.

Medicare and Medicaid: drugmaker copay cards are limited to private insurance, so people with government coverage usually look to a free medicine program or a charity fund, both on the help paying page.

Eligibility is decided by each program, so call the number listed before a prescription is filled.