TGTX TG Therapeutics Inc.

TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021. Details of the data presentations are included below.

“We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL.” Mr Weiss continued, “We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination.”

IwCLL 2021 PRESENTATION INFORMATION



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

  • Abstract Number: 1083667
  • Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST

  • Session: Session 6: Front-Line Therapy of CLL
  • Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland

Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

  • Abstract Number: 1083987
  • Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
  • Session: Session 8: New Agents in CLL Clinical Trials
  • Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY

Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

  • Abstract Number: 1083634
  • Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
  • Session: Poster Session

  • Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia

Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

  • Abstract Number: 1083523
  • Presentation Date/Time: Available on demand
  • Session: Virtual Poster Gallery
  • Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY

Currently, the conference agenda, including abstract titles, is available via the iwCLL website at . Full text abstracts will be publicly available on September 13, 2021.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at .



ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit , and follow us on Twitter  and .



UKONIQ® is a registered trademark of TG Therapeutics, Inc.



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. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, our most recent Quarterly Report filed on Form 10-Q, and our other filings with the U.S. Securities and Exchange Commission.

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 . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Investor Relations

Email:

Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:

Email:

Telephone: 1.877.575.TGTX (8489), Option 6



EN
30/08/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on TG Therapeutics Inc.

 PRESS RELEASE

TG Therapeutics Completes Enrollment in the Phase 3 ENHANCE Trial Eval...

TG Therapeutics Completes Enrollment in the Phase 3 ENHANCE Trial Evaluating its New Simplified Dosing Schedule for BRIUMVI NEW YORK, Oct. 28, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has completed in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated Day 1 and Day 15 dosing schedule for IV BRIUMVI® (ublituximab-xiiy), the company’s novel, glycoengineered, anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). The primary endpoint of this trial is non inferior exposure with ...

 PRESS RELEASE

New Data for BRIUMVI® Demonstrate 89.9% of Patients with Relapsing Mul...

New Data for BRIUMVI® Demonstrate 89.9% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 6 Years of Continuous BRIUMVI Treatment During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated d...

 PRESS RELEASE

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® ...

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® in Multiple Sclerosis at the 2025 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain. ...

 PRESS RELEASE

TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollme...

TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment Phase 3 trial to evaluate two subcutaneous BRIUMVI dosing regimens NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as several ex-US territories, as a one-hour intravenous (IV) infusion administered twice...

 PRESS RELEASE

TG Therapeutics to Participate in the H.C. Wainwright 27th Annual Glob...

TG Therapeutics to Participate in the H.C. Wainwright 27th Annual Global Investment Conference Fireside chat scheduled for Monday, September 8, 2025, at 10:30am ET NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the H.C. Wainwright 27th Annual Global Investment Conference, being held in New York, NY on September 8 – 10, 2025. The fireside chat is scheduled to take place on Monday, September 8, 2025, at 10:30am ET. A live webcast of the fires...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch