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.
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:
- 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- Drug:
- BRIUMVI
- Announced Date:
- April 18, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS).
AI Summary
TG Therapeutics, Inc. has secured a national contract with the U.S. Department of Veterans Affairs for its drug BRIUMVI® (ublituximab-xiiy). Under the contract, BRIUMVI is named as the preferred anti-CD20 antibody on the VA National Formulary specifically for treating patients with relapsing forms of multiple sclerosis (RMS). The agreement runs from June 17, 2024, to June 16, 2025, with potential one-year extensions that could expand the contract’s value to approximately $186 million over five years. The contract stipulates that BRIUMVI will be used for all new anti-CD20 therapy starts, unless there are clinical reasons not to, and offers physicians the option to switch existing patients from other therapies to BRIUMVI. TG Therapeutics highlighted that BRIUMVI’s unique one-hour, twice-a-year administration after the initial dose provides veterans with a more convenient treatment option.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- April 18, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics, Inc. announced two additional data presentations from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 American Academy of Neurology (AAN) annual meeting, being held in Denver, Colorado.
AI Summary
TG Therapeutics, Inc. announced that it will present two new data sets from its ULTIMATE I & II Phase 3 clinical trials at the 2024 American Academy of Neurology annual meeting in Denver, Colorado. These presentations focus on the use of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). One poster presentation reports that ublituximab significantly reduces radiological disease activity at 12 weeks in participants with highly active disease, while the other highlights data suggesting that starting ublituximab treatment earlier may improve long-term disability outcomes, especially among treatment-naïve patients.
The company emphasized its commitment to advancing research and improving treatment options for the multiple sclerosis community through these findings from the ULTIMATE trials.
Read Announcement- Drug:
- BRIUMVI
- Announced Date:
- April 15, 2024
- Indication:
- For the management of autoimmune disorders
Announcement
TG Therapeutics announced the presentation of 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 American Academy of Neurology (AAN) annual meeting, being held in Denver, Colorado. A link to the data presented yesterday is included below.
AI Summary
TG Therapeutics announced the presentation of data from the ULTIMATE I & II Phase 3 trials, which evaluated the safety and efficacy of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis, at the 2024 American Academy of Neurology (AAN) annual meeting in Denver, Colorado. The data, initially presented yesterday, comes from studies comparing BRIUMVI with teriflunomide and highlights robust clinical activity along with new insights from post-hoc analyses. These findings further support BRIUMVI’s utility as an important treatment option for those living with relapsing multiple sclerosis. TG Therapeutics’ CEO, Michael S. Weiss, emphasized that the trial results strengthen the profile of BRIUMVI and noted that additional data sets will be shared on Wednesday, April 17, 2024. For those interested, the detailed data presentation is available through the provided link.
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:
- 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
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