Company Spotlight: TG Therapeutics Inc.

(RTTNews) - Shares of TG Therapeutics Inc. (TGTX) are up an impressive 120% over the last four trading days.

TG Therapeutics is focused on developing novel treatments for B-cell malignancies and autoimmune diseases. The company's key drug candidate is TG-1101, a novel glyco-engineered, anti-CD20 monoclonal antibody, belonging to the same class as Roche's blockbuster cancer drug Rituxan, also known as MabThera.

As recently as March 6, 2017, the Company reported positive top line results from its phase III clinical trial evaluating TG-1101 in combination with AbbVie's approved Imbruvica in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).

In the phase III trial, dubbed GENUINE, the combination of TG-1101 and Imbruvica increased Overall Response Rate by more than 70% over Imbruvica alone.

A full analysis of the GENUINE data along with detailed efficacy and safety results will be submitted for presentation at a medical meeting in the first half of 2017 and the Company plans to meet with the FDA as soon as possible thereafter to discuss the filing of the data for accelerated approval.

The potential of TG-1101 is also being explored in patients with relapsing forms of multiple sclerosis (RMS), and a phase II study in this indication is ongoing.

In January of this year, the Company announced that enrollment in Part 1 of the ongoing phase II Multiple Sclerosis Study has been completed. The Part 1 of the study is exploring TG-1101 at an initial dose of 600 mg administered as a 150 mg infusion on day 1 and 450 mg infusion on day 15, followed by either 450 mg or 600 mg at week 24. As Part 2 of the trial, the Company has added expansion cohorts and will explore accelerated dosing of the initial 150 mg dose.

A phase III trial of TG-1101 in multiple sclerosis is expected to be initiated in the first half of this year.

Another product in the company's pipeline is TGR-1202, an orally available PI3K delta inhibitor.

An investigator initiated phase II study evaluating the safety and efficacy of TGR-1202 in combination with Imbruvica in patients with relapsed or refractory Diffuse Large B-cell Lymphoma is underway at the University of Nebraska Medical Center (UNMC).

The other ongoing clinical trials of the Company are:

-- A phase IIb clinical study comparing TG-1101 in combination with TGR-1202 against TGR-1202 alone in patients with previously treated Diffuse Large B-Cell Lymphoma, dubbed UNITY-DLBCL, initiated in June 2016.

-- A phase III clinical trial of TG-1101 in combination with TGR-1202 in treatment naive Chronic Lymphocytic Leukemia patients, dubbed UNITY-CLL, initiated in January 2016.

Recent event:

On March 9, 2017, the Company offered to sell 5.13 million shares of its common stock to the public at a price of $9.75 each. The underwriters have a 30-day option to purchase up to an additional 769,230 shares of common stock.

The gross proceeds from the offering are anticipated to be $50 million. The offering is scheduled to close on or about March 14, 2017.

What next?

The Company is all set to report results for the fourth quarter and year-end 2016, and provide a business outlook for 2017 on March 10, 2017 before 8:30am ET.

Shares of TGTX have gained over 150% year-to-date. The stock touched a 52-week high of $12 on Thursday, before closing the day's trading at $11.80, up 16.26%.