NEW YORK, April 06, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), were presented yesterday during an oral session at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington. Highlights of the presentation are outlined below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We were excited to have Dr. Steinman present [yesterday] during an oral session at AAN, additional relapse data from the ULTIMATE I & II trials. It is encouraging that both the time to first confirmed relapsed, and the proportion of patients who experienced a confirmed relapse were reduced with ublituximab treatment as compared to teriflunomide.” Mr. Weiss continued, “The ULTIMATE I & II trials support our current BLA for ublituximab to treat patients with RMS and we continue to work towards our PDUFA goal date of September 28, 2022.”

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)

• In ULTIMATE I and II, peripheral B-cell numbers declined rapidly after the first ublituximab infusion and remained low during treatment, which is consistent with ublituximab’s mechanism of action
• In the Phase 3 ULTIMATE I and II trials, the primary endpoint of ARR was significantly improved at 96 weeks for patients treated with ublituximab vs teriflunomide
• Both the time to first confirmed relapse and the proportion of patients with a confirmed relapse during treatment were reduced with ublituximab vs teriflunomide in both studies

The above presentation is also 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