NEW YORK, March 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, including one oral and three poster 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 American Academy of Neurology (AAN) annual meeting, being held April 2 – 7, 2022, in Seattle, Washington. Abstracts are now available online and can be accessed on the AAN meeting website at www.aan.com. Details of the presentations are outlined below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to be presenting additional data from the ULTIMATE I & II Phase 3 trails at the 2022 AAN annual meeting. We are particularly excited to see Dr. Steinman’s abstract be awarded an oral presentation, to showcase detailed relapse rate data highlighting that in the ULTIMATE trials both relapse rate and cumulative probability of relapse were significantly reduced with ublituximab compared to teriflunomide.” Mr. Weiss continued, “We look forward to the conference next month and to sharing more data from the ULTIMATE trials that continues to support the potential approval of ublituximab to treat patients with relapsing forms of multiple sclerosis.”Oral Presentation Title:Relapse Rate and Time to First Relapse Were Improved With Ublituximab vs Teriflunomide in the Phase 3 ULTIMATE I and ULTIMATE II Studies in Patients With Relapsing Multiple Sclerosis (RMS)

• Presentation Date/Time: Tuesday, April 5, 2022 at 10:15 AM PT
• Session: Clinical Trials Plenary Session – Oral Presentation
• Abstract Number: 1011
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University

Poster Presentation Title:Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis (RMS): Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) Evaluations From the Phase 3 ULTIMATE I and II Studies

• Presentation Date/Time: Sunday, April 3, 2022 at 11:45 AM-12:45 PM PT
• Session: Neighborhood 4 - P5: MS Clinical Trials and Therapeutics 1
• Abstract Number/Poster Number: 963/009
• Lead Author: Bruce A. C. Cree, MD, PhD, MAS, UCSF Weill Institute for Neurosciences, University of California San Francisco

Poster Presentation Title:Ublituximab Treatment Is Associated With a Significant Proportion of Patients Achieving No Evidence of Disease Activity (NEDA): Results From the Ultimate I and Ultimate II Phase 3 Studies of Ublituximab vs Teriflunomide in Relapsing Multiple Sclerosis (RMS)

• Presentation Date/Time: Sunday, April 3, 2022 at 5:30-6:30 PM PT
• Session: Neighborhood 4 - P6: MS Clinical Trials and Therapeutics 2
• Abstract Number/Poster Number: 992/005
• Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

Poster Presentation Title:Infusion-Related Reactions (IRRs) With Ublituximab in Patients With Relapsing Multiple Sclerosis (RMS): Post Hoc Analyses From the Phase 3 ULTIMATE I and II Studies

• Presentation Date/Time: Sunday, April 3, 2022 at 5:30–6:30 PM PT
• Session: Neighborhood 4 - P6: MS Therapeutics MOA and Safety 1
• Abstract Number/Poster Number: 1017/010
• Lead Author: Edward J. Fox, MD PhD, Central Texas Neurology Consultants, Round Rock, TX

Following the presentations, 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