TG Therapeutics Provides Business Update and Reports Third Quarter 2020 Financial Results

About this update from Tg Therapeutics, Inc.

[{"type":"text","content":"NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the third quarter ended September 30, 2020 and recent company developments.\n Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, “This has been a very exciting few months for TG especially sharing the first ever data from the UNITY-CLL Phase 3 trial last week showing that the trial met its primary endpoint of improvement in progression-free survival, as well as data from the UNITY-NHL trial which supported our NDA submission for umbralisib monotherapy. These data sets add to the growing body of evidence suggesting that umbralisib has a differentiated safety profile and support our long-term vision of U2 as a potential backbone for future combination therapies.” Mr. Weiss continued, “With PDUFA goal dates in February 2021 and June 2021 now set for our umbralisib NDA for the treatment of relapsed/refractory MZL and FL, respectively, our team is hard at work ensuring we are prepared for a successful launch in these indications. With a healthy balance sheet which includes a proforma cash position of approximately $325 million as of September 30, 2020, we are focused on preparing a BLA/NDA submission for U2 in CLL and importantly delivering on our remaining milestones for the year including topline results from our ULTIMATE I & II Phase 3 trials of ublituximab in MS.” Recent Developments and Highlights ASH 2020 Presentations:• Four abstracts have been accepted for presentation at the upcoming 62nd American Society of Hematology (ASH) annual meeting, to be held virtually December 5 – 8, 2020, including: • Results from the UNITY-NHL Phase 2 marginal zone lymphoma (MZL) and follicular lymphoma (FL) umbralisib monotherapy cohorts • Results from the UNITY-CLL Phase 3 trial evaluating the combination of umbralisib and ublituximab (U2) in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL) • Two triple therapy presentations, one evaluating the combination of U2 plus venetoclax in CLL, and a another evaluating the combination of U2 plus TG-1701, our BTK inhibitor, in patients with B-cell malignancies• Abstracts were made available last week and a call was held with leading investigators from our trials to review the data included in these abstracts...

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