Clinical Trials
63
25 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1993
Active, not recruiting
24
38.1%
Completed
15
23.8%
Not yet recruiting
1
1.6%
Recruiting
10
15.9%
Terminated
13
20.6%
- TG Therapeutics will present six years of long-term efficacy and safety data for BRIUMVI (ublituximab-xiiy) from the ULTIMATE I and II open-label extension studies at the 2025 ECTRIMS meeting in Barcelona. - The presentations will include updates from the ENHANCE study on modified dosing regimens and real-world clinical experience from the first Phase 4 observational study ENABLE for relapsing multiple sclerosis patients. - BRIUMVI is a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, approved in the U.S., EU, and UK for treating adults with relapsing forms of multiple sclerosis with demonstrated efficacy in pivotal trials involving 1,094 patients.
- TG Therapeutics reported a remarkable 91% year-over-year revenue increase in Q2 2025, primarily driven by strong sales of its multiple sclerosis treatment BRIUMVI. - The company raised its 2025 BRIUMVI U.S. net revenue target to $570-575 million and increased global revenue projections to approximately $585 million. - BRIUMVI has gained regulatory approval in the EU, UK, Switzerland, and Australia, with management citing strong physician confidence and uptake. - CEO Michael S. Weiss highlighted the continued momentum across all business aspects, positioning BRIUMVI to redefine multiple sclerosis treatment expectations.
- TG Therapeutics has commenced enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis, marking a significant milestone in the company's subcutaneous development program. - The randomized, open-label study will compare subcutaneous BRIUMVI administered every 8 or 12 weeks against the currently approved intravenous formulation, with the primary endpoint being non-inferior drug exposure at week 24. - If successful, BRIUMVI would become the only anti-CD20 therapy offering both healthcare provider-administered IV and patient self-administered subcutaneous options, potentially capturing an estimated 40% of the RMS CD20 market that prefers self-injectable therapies. - The company projects that positive trial data could support regulatory approval by 2028, expanding treatment flexibility for multiple sclerosis patients while broadening BRIUMVI's market opportunity.
- Roche announced that its Phase 3 MUSETTE trial testing a high-dose version of Ocrevus (ocrelizumab) failed to show additional benefit in slowing disability progression in relapsing multiple sclerosis patients. - The setback for Roche's MS therapy sent shares of rival drug developer TG Therapeutics higher, as investors reassessed competitive dynamics in the multiple sclerosis treatment landscape. - Despite the trial failure, Roche reported that the standard 600mg dose of Ocrevus demonstrated clinically meaningful results with the lowest annualized relapse rate observed in any Phase 3 study for relapsing MS.
- TG Therapeutics will showcase data from ULTIMATE I & II Phase 3 trials and ENHANCE Phase 3b trial evaluating BRIUMVI in relapsing multiple sclerosis at the upcoming ACTRIMS forum in Florida. - Key presentations will focus on the safety and tolerability of 30-minute BRIUMVI infusions, real-world experience data, and distinct disease activity trajectories compared to teriflunomide. - The ULTIMATE trials enrolled 1,094 RMS patients across 10 countries, demonstrating BRIUMVI's potential as a novel CD20-targeting treatment option for multiple sclerosis patients.
• TG Therapeutics has secured access to MaxCyte's flow electroporation technology to develop azercabtagene zapreleucel, an off-the-shelf CAR T-cell therapy for progressive multiple sclerosis. • The Phase 1 clinical trial will evaluate azer-cel in up to 32 patients with progressive MS forms, focusing on determining optimal dosing and safety profiles. • This innovative therapy targets CD19-expressing B-cells using donor-derived T-cells, potentially reducing MS-driving autoantibodies while avoiding graft-versus-host disease complications.
- TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (RMS). - The company anticipates $540 million in total global revenue for 2025, with $525 million expected from Briumvi sales, signaling continued growth and market penetration. - A pivotal program for a subcutaneous formulation of Briumvi is slated to begin in 2025, offering a more convenient administration route for RMS patients. - TG Therapeutics plans to initiate a Phase 1 trial for azer-cel in progressive MS, expanding its pipeline and addressing unmet needs in more advanced stages of the disease.
- The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. - Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). - Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. - Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.
- Several drugs approved under the FDA's accelerated approval pathway have been withdrawn from the market due to safety concerns or failure to confirm clinical benefit. - Pfizer pulled Oxbryta, a sickle cell disease therapy, after new data showed a higher risk of deaths and complications in treated patients. - Biogen and Eisai discontinued Aduhelm, an Alzheimer's drug, after a controversial approval and inauspicious rollout, focusing instead on Leqembi. - The FDA is now requiring confirmatory trials to be underway before granting accelerated approval to address delays and ensure clinical outcomes.
- Phase 3b ENHANCE study reveals that 30-minute infusions of BRIUMVI (ublituximab-xiiy) are well-tolerated in patients with relapsing forms of multiple sclerosis (RMS). - Data suggest patients switching from prior anti-CD20 therapies can eliminate the initial BRIUMVI infusion, streamlining the treatment process. - Rapid infusions were completed without interruptions, with infusion-related reactions being mild (Grade 1) and resolving completely, enhancing patient convenience. - These findings support ongoing efforts to optimize BRIUMVI dosing regimens, potentially leading to label-enabling studies and improved patient outcomes.
