Company Update (NASDAQ:TGTX): TG Therapeutics Inc Announces First Patient Enrolled in the Registration-Directed UNITY-DLBCL Phase 2b Trial

TG Therapeutics Inc (NASDAQ:TGTX) announced the enrollment of its first patient in its registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with TGR-1202, the Company’s orally available PI3K delta inhibitor, as well as TGR-1202 alone, in patients with previously treated Diffuse Large B-Cell Lymphoma (DLBCL).

The study, entitled “A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 alone in Patients with Previously Treated Diffuse Large B-Cell Lymphoma,” is being led by Owen A. O’Connor, MD, PhD, Professor of Medicine and Experimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center.  The primary objective of the study is to assess the efficacy of TGR-1202 alone and in combination with TG-1101 in patients with previously treated DLBCL as measured by Overall Response Rate (ORR).  The study will also provide important information as to the contribution of each asset, TGR-1202 and TG-1101, to the combination of both agents.  In addition to monitoring for safety and efficacy this study will analyze the impact of cell of origin (GCB vs. ABC ), mutational status and select biomarkers of efficacy.

Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, “We are excited to announce the enrollment of our first patient in our UNITY-DLBCL Phase 2b trial.  We believe the foundation of our company lies in the approval of TG-1101 + TGR-1202, our proprietary ‘1303′ combination, across a wide variety of b-cell disorders and this trial marks another important step forward in achieving our goal.  DLBCL is an area of significant unmet medical need, with no approved treatment options available for patients with relapsed/refractory disease and limited activity seen with other novel agents in this patient population. We are encouraged by the early data we have seen in our Phase I/II studies, as presented at the recent ASCO meeting, and look forward to evaluating the combination in this registration-directed trial.” (Original Source)

Shares of TG Therapeutics closed yesterday at $8.18, up $0.27 or 3.41%. TGTX has a 1-year high of $19.05 and a 1-year low of $6.95. The stock’s 50-day moving average is $8.43 and its 200-day moving average is $9.46.

On the ratings front, TGTX has been the subject of a number of recent research reports. In a report issued on May 31, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on TGTX, with a price target of $28, which implies an upside of 242.3% from current levels. Separately, on May 27, FBR’s Edward White reiterated a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Edward White have a total average return of -8.6% and 7.3% respectively. Aschoff has a success rate of 39.1% and is ranked #3866 out of 3903 analysts, while White has a success rate of 62.7% and is ranked #511.

The street is mostly Bullish on TGTX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $27.50, which represents a potential upside of 236.2% from where the stock is currently trading.

TG Therapeutics, Inc. is a biopharmaceutical company. It is focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The company develops two therapies targeting hematological malignancies: TG-1101 and TGR-1202. 


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