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TGTX Topline Results Ultimate I Ultimate Ii: Jumps 23%

ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate

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Leon Ziegler
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43 views2 pages

TGTX Topline Results Ultimate I Ultimate Ii: Jumps 23%

ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate

Uploaded by

Leon Ziegler
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Healthcare

Dec. 10, 2020 7:31 AM ET | TG Therapeutics, Inc. (TGTX) | By: Mamta Mayani, SA News Editor | 4
Comments

TG Therapeutics (NASDAQ:TGTX) jumps 23% premarket on positive topline


results from two global, Phase 3 studies, called ULTIMATE I & ULTIMATE II,
evaluating ublituximab, an investigational, glycoengineered anti-CD20 monoclonal
antibody, compared to teriflunomide in patients with relapsing forms of multiple
sclerosis (RMS).

The ULTIMATE I & II trials enrolled a total of 1,094 patients. Both studies met their
primary endpoint with ublituximab treatment demonstrating a statistically
significant reduction in annualized relapse rate (ARR) over a 96-week period
(p<0.005 in each trial).

Ublituximab resulted in an ARR of <0.10 in each of ULTIMATE studies, with a


relative reduction in ARR of ~60% and 50%, respectively, over teriflunomide.

Further analyses of both the studies including safety and secondary endpoints will
be presented at an upcoming medical congress, targeted in H1 2021.

Additionally, data from these studies are intended to support a BLA submission for
ublituximab in RMS targeted in mid-year 2021.

The company will host a conference call today at 8:30 AM ET to discuss the
ULTIMATE I & II topline results.

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