TG Therapeutics, Inc. (NASDAQ:TGTX)
Most of this year’s press for TG Therapeutics involved announcements of law firms asking clients who had held the shares between September, 2014 and October 2016, to contact them about joining in a class action lawsuit against the biotech company. But today TG Therapeutics Inc. (NASDAQ:TGTX) is making news for all the right reasons and TGTX is up almost 100% in mid-morning trading.
TG Therapeutics has been accused of making misleading or false public statements regarding an FDA Phase 3 clinical trial regarding the firm’s proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the company’s once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (“CLL”). The Phase III clinical trial, is referred to by the Company as “GENUINE”.
It is alleged by the law firms that TG Therapeutics Inc. made false and/or misleading statements and/or omitted material information concerning the GENUINE Phase III trial, assuring investors it was a “best-in-class treatment” that would be “successful” and “offer patients a novel chemo-free treatment option”. The deadline to become a plaintiff in the case is March 7, 2017.
Today, however, TG Therapeutics Inc. (NASDAQ:TGTX) saw its share price more than double when they released news that positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib achieved positive topline results in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).
The clinical study involved adult patients with high-risk chronic lymphocytic leukemia (CLL) who have undergone at least one prior therapy. The Phase 3 trial was designed to assess whether adding ublituximab would induce a statistically significant improvement in overall response rate – defined as at least 20 percent between the two groups of patients. TG Therapeutics reported the absolute difference between the two groups was about 30 percent.
Shares of TG Therapeutics Inc. (NASDAQ:TGTX) have gained since the beginning of the year despite the threats posed by the class action lawsuit. Over the past year, and prior to today, TGTX shares had lost over 40% but were actually up over 15% YTD. On Friday TGTX closed at $5.35 and have reached an inter-day high of $11.6 – representing a gain of over 115%.
Complete results are expected to be presented at a future medical meeting in the first half of 2017. TG Therapeutics Inc. (NASDAQ:TGTX) is expected to meet with the FDA to pursue accelerated approvals.
|Last Price a/o 11:08 AM EST||$ 10.60|
|Market Cap (mlns)||$ 306.50|
|Shares Outstanding (mlns)||57.29|
|Share Float (mlns)||40.91|
|Short Interest Ratio||13.67|
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.