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TG Therapeutics Recaps Schedule of Data Presentations at the Upcoming 62nd American Society of Hematology Annual Meeting and Exposition

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TG Therapeutics (NASDAQ: TGTX) announced data presentations for the 62nd American Society of Hematology (ASH) annual meeting, occurring virtually from December 5-8, 2020. Key presentations include:

  • Phase 3 UNITY-CLL Study: Umbralisib plus Ublituximab shows superiority over Obinutuzumab plus Chlorambucil in treating CLL.
  • Phase 2 UNITY-NHL Trial: Umbralisib exhibits clinical activity in relapsed/refractory indolent Non-Hodgkin Lymphoma.
  • Phase 1/2 Study: Combines Umbralisib, Ublituximab, and Venetoclax in patients with CLL.

The data will be available on TG's corporate website post-presentation.

Positive
  • Presentation of significant data supporting Umbralisib and Ublituximab combinations for treating hematological malignancies.
  • Discussions at a prominent annual meeting (ASH) enhance visibility and credibility in the oncology sector.
  • Clinical activity data from multiple studies may positively influence investor sentiment.
Negative
  • No immediate financial metrics or outcomes related to the presentations provided, leaving uncertainty about potential market impact.
  • Risks identified regarding regulatory approvals and clinical milestones may affect investor confidence.

NEW YORK, Dec. 03, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of data presentations at the upcoming 62nd American Society of Hematology (ASH) annual meeting and exposition, to be held virtually December 5 – 8, 2020.

ASH 2020 PRESENTATION DETAILS:

  • Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
    • Publication Number: 543
    • Oral Session: 642. CLL: Therapy, excluding Transplantation
    • Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
      • Presentation Time: 7:15 AM (Pacific Time)
    • Presenter: John G. Gribben, MD, D.Sc., Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom;
  • Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial
    • Publication Number: 2934
    • Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
    • Date and Time: Monday, December 7, 2020; 7:00 AM - 3:30 PM (Pacific Time)
    • Presenter: Pier Luigi Zinzani, MD, PhD, Institute of Hematology, “L. e A. Seràgnoli”, University of Bologna, Italy

  • Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
    • Publication Number: 3137
    • Session: 642. CLL: Therapy, excluding Transplantation: Poster III
    • Date and Time: Monday, December 7, 2020; 7:00 AM - 3:30 PM (Pacific Time)
    • Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY

  • Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies
    • Publication Number: 1130
    • Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
    • Date and Time: Saturday, December 5, 2020; 7:00 AM - 3:30 PM (Pacific Time)
    • Presenter: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia

Following each presentation during ASH 2020, the data presented will be available on TG’s corporate website at http://tgtxinc.com/publications.cfm. TG abstracts are publicly available via the ASH meeting website at www.hematology.org or on the company’s corporate website. 

ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS).  Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following:  the risk that interim, top-line, or other early clinical trial results, that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in final data sets or in future studies; the risk that we will not be able to meet the regulatory submission or clinical trial timelines that we project or achieve other anticipated milestones, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones; and the risk that our compounds will not receive regulatory approval or become commercially successful products.. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:
 
 Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com


FAQ

What are the main presentations by TG Therapeutics at ASH 2020?

TG Therapeutics will present data on Umbralisib and Ublituximab's effectiveness in treating CLL and NHL at the ASH annual meeting.

When is the ASH 2020 annual meeting?

The ASH 2020 annual meeting is scheduled for December 5-8, 2020.

What is the focus of TG Therapeutics' presentations at ASH 2020?

The presentations focus on the efficacy of Umbralisib and Ublituximab in treating chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma.

How can I access data presented by TG Therapeutics at ASH 2020?

Data presented will be available on TG Therapeutics' corporate website following each presentation.

What is the significance of the UNITY-CLL Study for TG Therapeutics?

The UNITY-CLL Study shows that Umbralisib plus Ublituximab is superior to existing treatments, which may impact TG Therapeutics' market position.

TG Therapeutics, Inc.

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