NEW YORK, NY / ACCESSWIRE / February 24, 2017 / Pomerantz LLP announces that a class action lawsuit has been filed against TG Therapeutics, Inc. ("TG Therapeutics" or the "Company") (TGTX) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 17-cv-00508, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired TG Therapeutics securities between September 15, 2014 and October 12, 2016, both dates inclusive (the "Class Period"), seeking to recover compensable damages caused by defendants' violations of the Securities Exchange Act of 1934.
If you are a shareholder who purchased TG Therapeutics securities during the Class Period, you have until March 7, 2017 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll free, ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies and autoimmune diseases: (i) TG-1101 (ublituximab), a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes; and (ii) TGR-1202, an orally available PI3K delta inhibitor for various hematologic malignancies.
Throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, and operation. Specifically, Defendants 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." As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On September 17, 2015, the Company announced that it had reached an agreement with the U.S. Food and Drug Administration ("FDA") regarding a Special Protocol Assessment ("SPA") on the design of a Phase III clinical trial for its 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."
The purpose of the Phase III GENUINE trial was to show that TG-1101, in combination with Imbruvica (the trade name for an ibrutinib-based small molecule drug used to treat B cell cancers), could show an improvement in overall response rate ("ORR") and progression-free survival ("PFS") in 330 previously-treated patient with certain cancer cell mutations.
On October 13, 2016, TG Therapeutics announced that the Company had filed an "amended protocol for its GENUINE Phase III trial," which entirely abandoned Part II of the Phase III GENUINE study designed to measure the combination's effect on progression-free survival, thereby annulling the SPA with the FDA. Accordingly, the study's sole primary endpoint was reduced to only overall response rate (ORR), as contemplated in Part I of the study, and the target enrollment was reduced to only 120 patients. As a result of cutting enrollment by more than half, the Company stated it could be another two years to reach 330 patients – the number needed to have sufficient powering to show a PFS benefit.
According to analysts, excluding patients who have already taken Imbruvica "is an obvious barrier to enrollment" and significantly increases the likelihood that the FDA will not approve the combination treatment.
On this news, TG Therapeutics' share price fell $2.24, or 27%, to close at $6.01 on October 17, 2016.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
SOURCE: Pomerantz LLP