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TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at 7th Congress of the European Academy of Neurology

Published: 2021-06-18 18:00:00 ET

NEW YORK, June 18, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II global, active controlled, 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), during the 7th Congress of the European Academy of Neurology (EAN). This data was previously presented at the American Academy of Neurology (AAN) 73rd Annual Meeting.

Oral Presentation Title:Ublituximab versus teriflunomide in relapsing multiple sclerosis (RMS): Results of the Phase 3 ULTIMATE I and II trials

The ULTIMATE I & II studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the Day 1 infusion (150mg over four hours). The studies were conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Additionally, data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in the third quarter of 2021.

Data highlights from the ULTIMATE I & II Phase 3 studies in patients with RMS include:

Primary Endpoint: Annualized Relapse Rate (ARR) Results

In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p

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