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TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis Presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

Published: 2022-02-25 12:30:00 ET

NEW YORK, Feb. 25, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, including additional analyses from the ULTIMATE I & II Phase 3 trials evaluating ublituximab, the Company’s investigational novel, glycoengineered anti-CD20 monoclonal antibody, compared to teriflunomide, in patients with relapsing forms of multiple sclerosis (RMS). Highlights from the data presentations are included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to share three new data presentations from the ULTIMATE I & II Phase 3 trials at the ACTRIMS annual forum. The data presented yesterday continue to highlight the benefits of ublituximab as a potential treatment option for patients with RMS. We look forward to continuing to evaluate data from the ULTIMATE I & II Phase 3 trials as we head toward our FDA PDUFA goal date of September 28, 2022 for ublituximab in RMS.”

Poster Presentation Title:Reduction in T1 Hypointense Lesions With Ublituximab vs Teriflunomide in the Phase 3 ULTIMATE I and II Studies in Relapsing Multiple Sclerosis

In pooled post hoc analyses, significant reductions in both the volume and number of new T1 hypointense lesions were seen with ublituximab vs teriflunomide at 96 weeks
- Mean change from baseline at 96 weeks (across all postbaseline timepoints) in T1 hypointense lesion volume was 4.9x lower ublituximab compared to teriflunomide, 0.0101 vs. 0.0491 respectively, a difference of -0.0390 (95% confidence interval, -0.0585 to -0.0195; P

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