NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) --  TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 24 – 26, 2022, in West Palm Beach, Florida. Abstracts are now available online and can be accessed on the ACTRIMS meeting website at www.forum.actrims.org. Highlights from the abstract and details of the presentations are outlined below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to have three abstracts accepted for presentation at the upcoming ACTRIMS forum, highlighting additional analyses from the ULTIMATE I & II Phase 3 trials. Each new analysis continues to be encouraging and we believe reinforces the utility of ublituximab as a potential treatment option for patients with RMS.” Mr. Weiss continued, “We look forward to sharing the full data sets at the upcoming ACTRIMS meeting.”

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

• Presentation Date/Time: Thursday, February 24, 2022 at 5:30 PM ET
• Session: PS1. Poster Session 1
• Abstract Number/Poster Number: 386/P108
• Lead Author: Bruce A. C. Cree, MD, PhD, MAS, UCSF Weill Institute for Neurosciences, University of California San Francisco

Poster Presentation Title:Neutralizing Antibodies and Antidrug Antibodies in the Ublituximab Phase 3 ULTIMATE I and II Studies in Relapsing Multiple Sclerosis

• Presentation Date/Time: Thursday, February 24, 2022 at 5:30 PM ET
• Session: PS1. Poster Session 1
• Abstract Number/Poster Number: 594/P103
• Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

Poster Presentation Title: Pharmacodynamics of B-Cell Depletion and Pharmacokinetics of the Novel Anti-CD20 Monoclonal Antibody Ublituximab in Patients With Relapsing Multiple Sclerosis

• Presentation Date/Time: Thursday, February 24, 2022 at 5:30 PM ET
• Session: PS1. Poster Session 1
• Abstract Number/Poster Number: 595/P105
• Lead Author: Edward J. Fox, MD PhD, Central Texas Neurology Consultants, Round Rock, TX

A copy of the above abstract can be found on the ACTRIMS meeting website. Following the presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide over a 96-week period (p