This section highlights FDA-related milestones and regulatory updates for drugs developed by TG Therapeutics (TGTX).
Over the past two years, TG Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BRIUMVI and BRIUMVI®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BRIUMVI FDA Regulatory Timeline and Events
BRIUMVI is a drug developed by TG Therapeutics for the following indication: For the management of autoimmune disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BRIUMVI
- Announced Date:
- April 15, 2026
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. , announced the completion of enrollment 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).
AI Summary
TG Therapeutics announced completion of enrollment in a global Phase 3 trial of subcutaneous BRIUMVI (ublituximab-xiiy), its anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). The study is comparing two subcutaneous dosing schedules—administration every 2 months versus every 3 months—and will evaluate the therapy’s efficacy and safety in a broad RMS population. Ublituximab-xiiy targets B cells, a type of immune cell involved in MS activity.
Top-line results from the trial are expected at year-end 2026 or in the first quarter of 2027, marking an important milestone for the program. BRIUMVI is currently approved in the U.S. for adults with RMS (including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS) and in the EU and UK for adults with active RMS. Information on patient support and authorized specialty distributors is available at briumvi.com.Read Announcement
- Drug:
- BRIUMVI
- Announced Date:
- March 9, 2026
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the publication of data from a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI® (ublituximab-xiiy) in people with highly active relapsing forms of multiple sclerosis (RMS).
AI Summary
TG Therapeutics announced publication of a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab‑xiiy) in people with highly active relapsing multiple sclerosis. The paper, led by Hans‑Peter Hartung, MD, appeared in Neurology and Therapy. The analysis found that BRIUMVI produced statistically significant reductions in relapse rates and MRI disease activity, and significantly higher rates of no evidence of disease activity (NEDA‑3), compared with teriflunomide.
The pooled dataset included 168 participants with highly active disease at baseline (88 treated with BRIUMVI, 80 with teriflunomide) who were followed for 96 weeks. Highly active disease was defined as two or more relapses in the prior year plus at least one gadolinium‑enhancing T1 lesion at baseline. The publication provides more efficacy details and also outlines important safety and prescribing information to consider.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- February 17, 2026
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the publication of long term/five-year data from the ongoing open-label extension (OLE) of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS).
AI Summary
TG Therapeutics published five-year results from the ongoing open‑label extension of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab‑xiiy) in adults with relapsing forms of multiple sclerosis. The report covers long‑term outcomes in patients who continued on BRIUMVI after the randomized studies, showing sustained disease control with extended treatment.
Key efficacy findings at year five showed an annualized relapse rate (ARR) of 0.020 — equivalent to one relapse every 50 patient‑years of treatment — indicating very low on‑treatment relapse activity. Other efficacy measures in the extension continued to reflect low disease activity, supporting durable benefit with prolonged dosing.
The overall safety profile remained consistent over five years of continuous treatment, with no new safety signals observed during long‑term follow‑up. Common adverse reactions reported in the trial program included infusion reactions and upper respiratory tract infections. These five‑year OLE data support sustained efficacy and a stable long‑term safety profile for BRIUMVI in adults with relapsing MS.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- February 6, 2026
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy), to be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held in San Diego, California.
AI Summary
TG Therapeutics announced it will present new data on BRIUMVI (ublituximab-xiiy) at the ACTRIMS annual forum in San Diego. Presentations include updates from the ENABLE real‑world study evaluating people with relapsing multiple sclerosis (RMS) treated with BRIUMVI. CEO Michael S. Weiss said the data reflect the company’s ongoing effort to advance clinical understanding of BRIUMVI and support the MS community. Lead authors include Carrie Hersh, DO, MSc (Cleveland Clinic), and K. Mok, PhD (TG Therapeutics).
Additional BRIUMVI data will be shown in a poster on multi‑protein biomarker test results from the ENHANCE study, led by S. McCurdy of Octave Bioscience. All presentations are available in the ACTRIMS ePoster gallery (www.forum.actrims.org). Information on authorized specialty distributors and important safety information for BRIUMVI can be found at www.briumvi.com.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- January 27, 2026
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy), to be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 5 – 7, 2026 in San Diego, California.
AI Summary
TG Therapeutics announced it will present new BRIUMVI (ublituximab-xiiy) data at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, Feb. 5–7, 2026, in San Diego. Abstracts are available on the ACTRIMS meeting website. The company outlined several poster presentations covering real‑world infusion experience, pediatric study designs, and biomarker results.
Scheduled presentations include: ENABLE — “Real‑World Infusion Experience with Ublituximab” (Poster 387/P413) on Friday, Feb. 6, 6:45–7:30pm PST, led by Carrie Hersh, DO; ULTIMATE KIDS I dose‑confirmation (Poster 306/P115) on Thursday, Feb. 5, 6:45–7:30pm PST, led by K. Mok, PhD; ULTIMATE KIDS II Phase 3 study design (307/P116) on Thursday, Feb. 5, 6:00–6:45pm PST, led by K. Mok; and an ENHANCE biomarker poster (538/P040) on Thursday, Feb. 5, 6:00–6:45pm PST, led by S. McCurdy. After the forum, the presented data will be posted on TG Therapeutics’ Publications page.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- May 30, 2025
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below.
AI Summary
TG Therapeutics, Inc. recently announced that it presented new data on BRIUMVI® (ublituximab-xiiy) at the 2025 Consortium of Multiple Sclerosis Centers annual meeting. The company shared three presentations focusing on patients with relapsing forms of multiple sclerosis (RMS). One presentation highlighted that decreases in serum immunoglobulin levels were not linked to serious infections with long-term treatment. A second review detailed real‐world observations on how patients tolerated BRIUMVI infusions. The third presentation provided updated safety information from a study on 30-minute infusion sessions. Links to each presentation were provided on the company’s website, allowing for further exploration of the data. TG Therapeutics expressed enthusiasm about the compelling BRIUMVI data and looks forward to sharing more updated findings as the year continues.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- May 27, 2025
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 28-31, 2025 in Phoenix, Arizona.
AI Summary
TG Therapeutics, Inc. announced its schedule for a series of presentations at the upcoming 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting in Phoenix, Arizona, from May 28-31, 2025. The presentations will spotlight the latest BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS).
At the event, experts including Dr. Bruce Cree, Dr. Edward Fox, and Dr. John Foley will present poster sessions on topics such as serum immunoglobulin levels, real-world infusion tolerability, and updates on 30-minute infusion infusions from the ENHANCE study. Abstracts for these presentations are available online via the CMSC website at www.mscare.org/2025. This gathering offers an important opportunity to share emerging data on BRIUMVI’s efficacy and safety in treating RMS, further supporting its role in the management of the disease.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- March 7, 2025
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting, being held April 5 - 9, 2025, in San Diego, California.
AI Summary
TG Therapeutics, Inc. has announced its schedule for presenting new data on BRIUMVI® (ublituximab-xiiy) at the American Academy of Neurology 2025 annual meeting in San Diego, California, from April 5 to 9, 2025. The presentations will focus on BRIUMVI data for patients with relapsing forms of multiple sclerosis (RMS). Several poster presentations are planned, including studies on serum immunoglobulin levels and their lack of association with serious infections, findings from a real-world observational survey on infusion tolerability, and real-world evidence from the ENABLE Phase 4 observational study. Additional topics include five-year data from open-label extension studies and results from a modified BRIUMVI regimen. Abstracts for the presentations are now available on the AAN meeting website.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- February 27, 2025
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the presentation of data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held in West Palm Beach, Florida.
AI Summary
TG Therapeutics, Inc. announced new data presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum in West Palm Beach, Florida. The presentations cover findings from the ULTIMATE I and II Phase 3 trials and the ENHANCE Phase 3b trial, which evaluated BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). Notably, updated ENHANCE data demonstrated that over 80 patients received a 30-minute maintenance BRIUMVI infusion with a consistent safety and tolerability profile. Additionally, a single-center retrospective study presented by Dr. John Foley reviewed data from more than 160 patients, showing a safety profile similar to that seen in the Phase 3 trials. These findings support the potential benefits of BRIUMVI as a treatment option for RMS, with evidence suggesting improvements for patients who had suboptimal responses to previous anti-CD20 therapies.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- February 18, 2025
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the schedule of presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) to be presented at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 27 – March 1, 2025, in West Palm Beach, Florida.
AI Summary
TG Therapeutics, Inc. announced the schedule for several presentations that will highlight data from its ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). These sessions will be held during the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, taking place from February 27 to March 1, 2025, in West Palm Beach, Florida.
Key presentations include discussions on the safety and tolerability of shortened, 30-minute ublituximab infusions from the ENHANCE study, as well as analyses of genetic diversity and Fc biology in RMS. The abstracts, available on the ACTRIMS meeting website, further detail the innovative approaches behind BRIUMVI’s use in improving treatment outcomes for RMS patients.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- September 18, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced updated data presentations including new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, where we and our partner in Europe, Neuraxpharm, are exhibiting.
AI Summary
TG Therapeutics, Inc. recently presented updated long-term data from its ULTIMATE I and II Phase 3 trials at the 2024 ECTRIMS meeting. The new five-year results, shown alongside efforts by their European partner Neuraxpharm, highlight the sustained benefits of BRIUMVI (ublituximab-xiiy) in treating patients with relapsing forms of multiple sclerosis (RMS). The data revealed that patients maintained low relapse rates over the five-year period, supporting the drug’s ability to reduce the risk of relapses over time.
These findings also demonstrate that the safety profile of BRIUMVI remained consistent during prolonged treatment, with no new safety concerns appearing. The long-term results suggest that continuous treatment with BRIUMVI may offer a reliable, high-efficacy option for managing RMS, providing valuable support to both clinicians and patients as they consider effective treatment strategies.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- September 5, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the schedule of upcoming data presentations, highlighting data from both the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 18 – 20, 2024, in Copenhagen, Denmark.
AI Summary
TG Therapeutics, Inc. has announced its upcoming data presentations at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting in Copenhagen, Denmark, set for September 18–20, 2024. The company will showcase important results from both the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial, which evaluate the safety and effectiveness of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). These trials are key in understanding the long-term benefits and tolerability of BRIUMVI for RMS patients. Data will be shared through poster presentations and an ePoster, providing insights into the treatment’s performance and potential advantages over other therapies. Details about the presentations, including access to abstracts online via the ECTRIMS meeting website, are now available. This schedule highlights TG Therapeutics’ commitment to advancing treatment options for MS.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- May 31, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting.
AI Summary
TG Therapeutics, Inc. announced that new presentations are available at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. These presentations showcase the study designs for post‐marketing studies of BRIUMVI® (ublituximab-xiiy), a treatment for patients with relapsing forms of multiple sclerosis (RMS). The studies focus on important areas such as evaluating the concentration of BRIUMVI in breast milk and examining pregnancy and infant outcomes in patients treated with the therapy. Dr. Riley Bove from UCSF led both projects and highlighted the designs during the meeting. Interested individuals can access these presentations on TG Therapeutics’ website in the Publications section under the Pipeline area. This effort reflects the company's ongoing commitment to gather real-world evidence and further understand BRIUMVI’s profile and benefits for RMS patients.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- May 28, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced the schedule of upcoming presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 29 – June 1, 2024, in Nashville, Tennessee.
AI Summary
TG Therapeutics, Inc. announced that it will present the study designs for post-marketing studies of its drug BRIUMVI® (ublituximab-xiiy) at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting in Nashville, Tennessee, scheduled for May 29 – June 1, 2024. The presentations are focused on gathering real-world data on BRIUMVI when used in patients with relapsing forms of multiple sclerosis (RMS). Two poster presentations will highlight these studies: one evaluating the presence and concentration of BRIUMVI in breast milk, and another detailing a prospective pregnancy registry that tracks pregnancy and infant outcomes in patients treated with BRIUMVI. Abstracts are available online on the CMSC meeting website and on TG Therapeutics’ publications page, offering detailed insights into these important post-marketing studies.
Read Announcement
BRIUMVI® (ublituximab-xiiy) FDA Regulatory Timeline and Events
BRIUMVI® (ublituximab-xiiy) is a drug developed by TG Therapeutics for the following indication: For treat relapsing forms of multiple sclerosis (MS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- March 6, 2026
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology (AAN) 2026 annual meeting, being held April 18 - 22, 2026, in Chicago, Illinois.
AI Summary
TG Therapeutics announced it will present data on BRIUMVI® (ublituximab‑xiiy) for patients with relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology (AAN) 2026 annual meeting, April 18–22, 2026, in Chicago. The company said it will release an upcoming schedule of presentations that highlight clinical findings for BRIUMVI in RMS populations.
The presentations are expected to give clinicians and researchers access to detailed trial data that may clarify BRIUMVI’s clinical profile in relapsing MS, including efficacy, safety and tolerability findings and effects on relapse activity and imaging measures. TG’s sessions should help inform treatment decisions, patient selection and future research directions. TG will publish the full presentation schedule ahead of the AAN meeting so attendees can review the timing and format (oral presentations and posters) of the data sessions.
Read Announcement- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- October 28, 2025
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. announced that enrollment has completed in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated Day 1 and Day 15 dosing schedule for IV BRIUMVI® (ublituximab-xiiy), the company's novel, glycoengineered, anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS).
AI Summary
TG Therapeutics announced enrollment completion in its Phase 3 ENHANCE trial, a double-blind, placebo-controlled study testing a consolidated dosing schedule for IV BRIUMVI® in relapsing multiple sclerosis patients. The study compares a single infusion on Day 1 with the standard two infusions on Day 1 and Day 15, measuring drug exposure at week 16 as the primary endpoint. Participants are randomized to receive either 600 mg BRIUMVI on Day 1 with a placebo on Day 15, or a 150 mg dose on Day 1 followed by 450 mg on Day 15.
BRIUMVI, already approved as a twice-yearly, one-hour IV treatment, may offer even greater convenience if the simplified dosing maintains equivalent exposure. Positive results could support a new regimen launch in 2027, improving efficiency for infusion centers and patient experience. The trial also evaluates safety and MRI outcomes, including T1 Gadolinium-enhancing lesions.
Read Announcement- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- September 10, 2025
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain.
AI Summary
TG Therapeutics, Inc. announced that it will present new data on BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) at the 2025 ECTRIMS annual meeting in Barcelona, Spain, held September 24–26. Abstracts are now available on the ECTRIMS website.
An oral presentation on the long-term efficacy and safety of ublituximab from six years of the ULTIMATE I & II open-label extension will be delivered on September 24 at 14:55 CEST by Dr. Bruce Cree. A poster on the safety and tolerability of a modified ublituximab dosing regimen from the ENHANCE study will appear as an e-poster starting September 24 and remain online for three months, led by Dr. Barry A. Singer.
A second e-poster, led by Dr. Carrie Hersh, will share real-world clinical experience from the ENABLE Phase 4 observational study, also available from September 24 for three months. Following the congress, all presented data will be posted in the Publications section on TG Therapeutics’ website. BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody designed to deplete B-cells and treat relapsing MS.
Read Announcement- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- September 8, 2025
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. 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).
AI Summary
TG Therapeutics has begun enrolling in a Phase 3 trial of subcutaneous BRIUMVI (ublituximab-xiiy) for relapsing multiple sclerosis. Currently given as a twice-yearly IV infusion, BRIUMVI is an anti-CD20 antibody. The subcutaneous version aims to let adult patients self-inject at home, offering more flexibility. TG believes it could reach 40% of RMS patients who prefer injectables. If successful, data may support approval in 2028, expanding treatment options.
The trial is non-inferiority, randomized, open-label, parallel-group and multicenter. Participants will be assigned to one of three arms: subcutaneous dosing every 8 or 12 weeks, or the approved IV schedule. Researchers will evaluate drug levels, effects on B-cells, safety, imaging and clinical outcomes. The primary goal is to show that subcutaneous BRIUMVI achieves similar blood exposure, measured by area under the curve at week 24.
Read Announcement- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- April 8, 2025
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below.
AI Summary
TG Therapeutics, Inc. recently presented new data on BRIUMVI® (ublituximab-xiiy) for patients with relapsing forms of multiple sclerosis (RMS) at the American Academy of Neurology 2025 annual meeting. The presentations highlighted real-world findings, including results from the ENAMOR survey, which collected data from about 400 patients across 21 MS centers. This survey showed a favorable tolerability profile with fewer infusion-related reactions during the first BRIUMVI dose, a benefit possibly linked to the use of acetaminophen as pre-medication. Other presentations at the meeting focused on the ENABLE Phase 4 observational study and long-term safety outcomes, noting that serious infections occurred at rates similar to clinical trials and no cases of progressive multifocal leukoencephalopathy (PML) were observed. These findings underscore TG Therapeutics’ commitment to enhancing patient care and exploring the real-world impact of BRIUMVI in RMS treatment.
Read Announcement- Drug:
- BRIUMVI® (ublituximab-xiiy)
- Announced Date:
- April 7, 2025
- Indication:
- For treat relapsing forms of multiple sclerosis (MS).
Announcement
TG Therapeutics, Inc. announced the publication of two journal articles one describing the evolution of CD20 treatments for multiple sclerosis (MS) and the other detailing the experience of seven individuals with MS who switched to BRIUMVI® (ublituximab-xiiy) from a different anti-CD20 monoclonal antibody therapy due to efficacy or tolerability concerns.
AI Summary
TG Therapeutics, Inc. announced the publication of two journal articles related to CD20 treatments for multiple sclerosis (MS). One article explains how CD20 therapies have evolved, discussing improvements in drug design, mechanisms of action, and patient tolerability. It offers insights into why switching between CD20 antibodies can be a good strategy for managing MS.
The other article presents a case series of seven patients with MS who switched to BRIUMVI® (ublituximab-xiiy) after experiencing issues such as reduced effectiveness or side effects with their previous anti-CD20 therapy. These cases provide early evidence that switching within the CD20 class may improve patient outcomes. The publications highlight the potential benefits of using BRIUMVI and support further research into treatment strategies for those with MS.
Read Announcement
