TG Therapeutics, Inc.

TG Therapeutics Announces Phase 1 Data Evaluating Azer-cel in Progressive Multiple Sclerosis in a Late-Breaking Oral Presentation at MSToronto2026

TG Therapeutics presented first-in-human-class Phase 1 data for azer-cel, an off-the-shelf allogeneic CD19 CAR-T, in progressive multiple sclerosis at the ACTRIMS-ECTRIMS meeting in Toronto. Across 26 heavily pre-treated participants, no Grade 3+ cytokine release syndrome, ICANS, or graft-versus-host disease was observed, and 89% of evaluable patients had stable or improved EDSS disability scores at Day 90, with three achieving at least 2.0-point improvements. B-cell depletion in blood and CSF confirmed biological activity, and dose escalation with longer follow-up is ongoing. The data are preliminary, open-label, and small-N, so the clinical signal must be replicated before any regulatory pathway is clear.

•9d ago

TG Therapeutics Highlights New Clinical Data Across Multiple Sclerosis Portfolio at MSToronto2026

TG Therapeutics presented new MS portfolio data at MSToronto2026, headlined by seven-year BRIUMVI results showing 88.3% of continuously treated patients free from confirmed disability progression and a Year 7 annualized relapse rate of 0.018. Positive Phase 3 ENHANCE results met their primary endpoint, showing a single 600 mg Day 1 infusion is bioequivalent to the approved two-dose initiation regimen, while Phase 1 subcutaneous data (bioavailability >60%) support a quarterly dosing schedule in a fully enrolled Phase 3 trial. Real-world ENABLE data (99.2% relapse-free among 1,076 participants) and switch data from ocrelizumab further bolster BRIUMVI's competitive profile, and a late-breaking Phase 1 oral presentation of azer-cel in progressive MS is scheduled for October 23, 2026.

•11d ago

TG Therapeutics Announces Publication of Five-Year Comparative Analysis of BRIUMVI Versus Ocrelizumab and Ofatumumab in Relapsing Multiple Sclerosis

TG Therapeutics announced publication in Multiple Sclerosis and Related Disorders of a five-year matching-adjusted indirect comparison showing BRIUMVI with lower relapse activity and lower risk of 24-week confirmed disability progression versus ocrelizumab and ofatumumab. In the analysis of 545 BRIUMVI-treated ULTIMATE I/II patients, the relative hazard of CDP24 was 44% lower versus ocrelizumab (HR 0.560) and 49% lower versus ofatumumab (HR 0.509), with annualized relapse rates falling to 0.030-0.032 by Year 5. The findings are explicitly exploratory, funded by European partner Neuraxpharm, and require confirmation in direct comparative studies — but they support BRIUMVI's long-term efficacy narrative for commercial differentiation.

•20d ago

TG Therapeutics Announces Schedule of Data Presentations at MSToronto2026

TG Therapeutics announced its presentation schedule for the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto2026) in Toronto, October 21-23, 2026. The headline item is a late-breaking oral presentation on October 23 with initial clinical results from the Phase 1 TG-Azercel-101 study evaluating azer-cel, an allogeneic off-the-shelf CD19-directed CAR T-cell therapy, in progressive multiple sclerosis. Additional BRIUMVI presentations cover Phase 3 ENHANCE data supporting a single dose initiation schedule, full Phase 1 subcutaneous BRIUMVI results, seven-year clinical outcomes, and real-world evidence. No efficacy or safety figures were disclosed in this release; the full azer-cel abstract will be available October 21, 2026, making it a near-term catalyst.

•24d ago

TG Therapeutics Reports Second Quarter 2026 Financial Results and Raises BRIUMVI® Revenue Guidance

TG Therapeutics reported Q2 2026 total revenue of $240.3 million, driven by a 64% year-over-year increase in BRIUMVI U.S. net product sales to $227.7 million. Management raised full-year 2026 guidance, targeting approximately $950 million in total global revenue and $890 million to $905 million in BRIUMVI U.S. net sales, putting the company on track for a $1 billion annualized run rate by year-end. The company reported positive Phase 3 ENHANCE data supporting a simplified single-infusion regimen and favorable Phase 1 subcutaneous BRIUMVI data, ending the quarter with $612.3 million in cash.

•2mo ago

TG Therapeutics Announces Initiation of Phase 2 Trial Evaluating BRIUMVI in Patients with Treatment-Resistant Schizophrenia

TG Therapeutics has initiated a Phase 2 clinical trial evaluating BRIUMVI (ublituximab-xiiy) in adults with treatment-resistant schizophrenia. The open-label study will enroll approximately 60 patients receiving standard-of-care antipsychotics, with the primary endpoint measuring a 20% reduction in PANSS total score at Week 12. CEO Michael Weiss cited emerging evidence linking immune dysfunction to schizophrenia, noting BRIUMVI's established safety profile makes it a compelling candidate for this new indication.

•3mo ago

The Quest to Repair What Multiple Sclerosis Takes Away

Bristol Myers Squibb announced that the European Commission has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for adult and adolescent patients with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval establishes the Opdivo plus AVD regimen as the first immunotherapy-based treatment available in the European Union for newly diagnosed advanced cHL.

•4mo ago

TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial

TG Therapeutics reported positive topline Phase 1 data for subcutaneous BRIUMVI in myasthenia gravis, showing 82% of patients achieved a Minimal Clinically Important Difference in MG-ADL scores with a mean improvement of 4.6 points at Week 24. The safety profile appeared consistent with the established intravenous formulation, supporting the continued development of the subcutaneous delivery method. Based on these results, the company initiated a potentially registration-directed Phase 2 trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in approximately 120 patients. This sequential approach aims to combine the rapid symptom control of FcRn inhibition with the sustained disease modification of B-cell depletion therapy to reduce treatment burden.

•4mo ago

TG Therapeutics Announces Positive Results from Phase 1 Trial Evaluating Subcutaneous BRIUMVI® (ublituximab-xiiy)

TG Therapeutics reported positive Phase 1 results for its subcutaneous formulation of BRIUMVI, showing >60% bioavailability relative to the IV version and no new safety signals. Pharmacokinetic modeling indicates that both quarterly and every-other-month subcutaneous dosing regimens will likely meet the non-inferiority primary endpoint in the ongoing Phase 3 trial. Top-line Phase 3 data is expected in late 2026 or early 2027, with a potential approval for the subcutaneous version in 2028 if successful.

•4mo ago

TG Therapeutics Announces Publication of Post-Hoc Data from the Phase 3 ULTIMATE I & II Trials in Treatment Naive Patients with Relapsing Forms of MS Published in Frontiers in Immunology

TG Therapeutics announced the publication of post-hoc pooled data from its Phase 3 ULTIMATE I and II trials in Frontiers in Immunology. The analysis showed BRIUMVI reduced annualized relapse rates by 56.7% versus teriflunomide in treatment-naïve patients, with an 82.7% NEDA-3 response rate compared to 23.1% for the comparator. These results reinforce the efficacy profile of BRIUMVI in early-stage relapsing multiple sclerosis, supporting the company's strategy for high-efficacy therapy adoption.

•5mo ago

TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial

TG Therapeutics announced positive topline results from its Phase 3 ENHANCE trial for BRIUMVI, meeting the primary endpoint of bioequivalence between the current two-infusion initiation regimen and a new single-infusion regimen. The study demonstrated that a single 600 mg infusion on Day 1 provides comparable drug exposure to the current 150 mg Day 1 and 450 mg Day 15 regimen, with a geometric mean ratio of approximately 1.0. Safety profiles were consistent with prior studies, with no new safety signals and fewer infusion-related reactions in the consolidated arm. TG Therapeutics plans to submit a supplemental BLA in the second half of 2026.

•5mo ago

TG Therapeutics Announces Data Presentations for BRIUMVI® at the 2026 Consortium of Multiple Sclerosis Centers Annual Meeting

TG Therapeutics is presenting four data sets for its approved MS drug BRIUMVI at the 2026 CMSC annual meeting, highlighting positive real-world and observational results. New analyses from the Phase 4 ENABLE study show significant improvements in patient-reported outcomes, with benefits observed as early as Day 15 and sustained through Week 48. Real-world data indicates strong disease control for patients transitioning from other therapies, with 99.4% remaining relapse-free and an annualized relapse rate of just 0.011.

•5mo ago

TG Therapeutics Reports First Quarter 2026 Financial Results and Raises BRIUMVI Revenue Guidance

TG Therapeutics reported Q1 2026 revenue of approximately $205 million, up 71% year-over-year, with BRIUMVI U.S. net product revenue of $194.8 million representing 63% quarterly growth. Net income came in at $19.8 million, or $0.12 per share, compared to $5.1 million in the prior year. Based on the strong start to 2026, the company raised full-year 2026 guidance for total global revenue to approximately $925 million and BRIUMVI U.S. net product revenue to $885-900 million, up from the prior range of $825-850 million. The company also secured $500 million in non-dilutive capital from Blue Owl Capital and expanded its share repurchase program from $100 million to $300 million, of which $200 million remains.

•5mo ago