SAN DIEGO & NEW YORK--(EON: Enhanced Online News)--Shareholder rights law firm Robbins Arroyo LLP announces that a class action complaint was filed against TG Therapeutics, Inc. (NASDAQCM: TGTX) in the U.S. District Court for the Southern District of New York. The complaint is brought on behalf of all purchasers of TG Therapeutics securities between September 15, 2014 and October 12, 2016, for alleged violations of the Securities Exchange Act of 1934 by TG Therapeutics' officers and directors. TG Therapeutics, a biopharmaceutical company, focuses on the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases primarily in the Unites States. The company is developing two therapies targeting hematological malignancies and autoimmune diseases, known as TG-1101 and TGR-1202.
“The GENUINE study, as amended, remains a robust, randomized clinical trial, which we believe, if positive, could support accelerated approval for patients with relapsed/refractory high-risk [Chronic Lymphocytic Leukemia].”
View this information on the law firm's Shareholder Rights Blog: www.robbinsarroyo.com/shareholders-rights-blog/tg-therapeutics-inc
TG Therapeutics Accused of Misrepresenting Its Drug Trial
According to the complaint, on September 17, 2015, TG Therapeutics announced that it had reached an agreement with the U.S. Food and Drug Administration ("FDA") regarding a Special Protocol Assessment on the design of a Phase 3 clinical trial for TG-1101 and TGR-1202. The purpose of the Phase 3 trial, referred to as the GENUINE trial, was to show that TG-1101 could show an improvement in overall response rate and progression-free survival ("PFS") in 330 previously-treated patients with certain cancer cell mutations. The complaint alleges that TG Therapeutics officials omitted material information concerning the Phase 3 trial, assuring investors that it was a "best-in-class" treatment that would be "successful" and "offer patients a novel chemo-free treatment option." In addition, TG Therapeutics allegedly failed to implement a proper screening protocol in the GENUINE enrolling sites and was not enrolling patients at the required rate for the study to be completed on time. Finally, contrary to the company's representations, the trial would never get 330 enrolled patients and PFS was not an achievable endpoint.
On October 13, 2016, TG Therapeutics issued a press release announcing that it had filed with the FDA an amended protocol for the GENUINE Phase 3 trial, stating, "The GENUINE study, as amended, remains a robust, randomized clinical trial, which we believe, if positive, could support accelerated approval for patients with relapsed/refractory high-risk [Chronic Lymphocytic Leukemia]." That same day, TheStreet published an article stating that TG Therapeutics had long suffered from a management credibility problem. The article further pointed out that the company cut planned enrollment for the GENUINE trial by one third, eliminated important efficacy endpoints, and generally exposed the company to more risk. On this news, TG Therapeutics' stock declined by approximately 27% to close at $6.01 per share on October 17, 2016.
TG Therapeutics Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the shareholder information form on the firm's website.
Robbins Arroyo LLP is a nationally recognized leader in shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested.
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