Law Firm Pomerantz Announces Class Action Filing
NEW YORK, July 18 12, 2022 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against TG Therapeutics, Inc. (“TG Therapeutics” or the “Company”) (NASDAQ: TGTX) and certain of its officers. The class action, filed in the United States District Court for the Southern District of New York and registered as 22-cv-06106, is on behalf of a class consisting of all persons and entities other than defendants. who purchased or otherwise acquired TG Therapeutics securities between January 15, 2020 and May 31, 2022, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of federal securities and to seek remedies under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its senior executives.
If you are a shareholder who purchased or otherwise acquired securities of TG Therapeutics during the class period, you have until September 16, 2022 to ask the court to name you as the lead plaintiff in the class. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those making inquiries by email are encouraged to include their mailing address, phone number and number of shares purchased.
[Click here for information about joining the class action]
TG Therapeutics, a commercial-stage biopharmaceutical company, is focused on acquiring, developing and commercializing novel treatments for B-cell malignancies and autoimmune diseases. The Company’s therapeutic product candidates include Ublituximab, an investigational genetically engineered monoclonal antibody for the treatment of B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (“CLL”) and relapsing forms of multiple sclerosis; and Umbralisib, or UKONIQ, an oral PI3K-delta and CK1-epsilon inhibitor for the treatment of CLL, marginal zone lymphoma, and follicular lymphoma.
In January 2020, TG Therapeutics initiated an ongoing New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”), seeking expedited approval of Umbralisib as a treatment for patients with previously treated marginal zone lymphoma (“MZL”) and follicular lymphoma (“FL”) (the “Umbralisib MZL/FL NDA”).
In December 2020, TG Therapeutics initiated a continuing Biologics License Application (“BLA”) submission to the FDA for Ublituximab in combination with Umbralisib (together, “U2”), as a treatment for patients with CLL (the “U2 BLA”).
In May 2021, TG Therapeutics submitted a Supplemental New Drug Application (“sNDA”) for Umbralisib to add an indication for CLL and small lymphocytic lymphoma (“SLL”) in combination with Ublituximab (the “sNDA U2”).
In September 2021, TG Therapeutics submitted a BLA to the FDA for Ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (“RMS”) (the “Ublituximab RMS BLA”).
The Complaint alleges that throughout the Class Period, the Defendants made materially false and misleading statements regarding the company’s business, operations and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) clinical trials revealed significant concerns related to the benefit/risk ratio and overall survival data of Ublituximab and Umbralisib; (ii) therefore, it was unlikely that the Company would be able to obtain FDA approval for Umbralisib MZL/FL NDA, U2 BLA, U2 sNDA or Ublituximab RMS BLA in their current forms; (iii) as a result, the Company had significantly overestimated the clinical and/or commercial prospects of Ublituximab and Umbralisib; and (iv) as a result, the Company’s public statements were materially false and misleading at all material times.
On November 30, 2021, TG Therapeutics issued a press release “announcing[ing] the U.S. Food and Drug Administration (FDA) has informed the company that it plans to hold an Oncology Drug Advisory Committee (ODAC) meeting as part of its review of the Biologics License Application ( BLA)/Supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). TG Therapeutics stated that “[t]The FDA has informed the company that potential issues and discussion topics for the ODAC include: the benefit-risk ratio of U2 combination in the treatment of CLL or LLS, and the benefit-risk ratio of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). Additionally, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and grade 3-4), discontinuations due to adverse events, and dose modifications , should be reconsidered. indicating that “[t]The FDA concern that prompted the ODAC meeting appears to stem from an early overall survival analysis of the UNITY-CLL trial.
On this news, TG ‘Therapeutics’ stock price fell $8.16 per share, or 34.93%, to close at $15.20 per share on November 30, 2021.
Then, on April 15, 2022, TG Therapeutics issued a press release “announcing[ing] that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination called U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The press release stated that “[t]The decision to withdraw was based on recently updated overall survival (OS) data from the Phase 3 UNITY-CLL trial which showed an increasing OS imbalance.
On this news, TG Therapeutics’ stock price fell $1.93 per share, or 21.81%, to close at $6.92 per share on April 18, 2022.
Then, on May 31, 2022, TG Therapeutics issued a press release announcing that the FDA had extended the prescription drug user fee law date for ublituximab until December 28, 2022 “to allow time to review a submission provided by the company in response to an FDA request.” request for information, which the FDA considered a major amendment.
On this news, TG Therapeutics’ stock price fell $0.75 per share, or 14.51%, to close at $4.42 per share on May 31, 2022.
Finally, on June 1, 2022, the FDA announced that due to safety concerns, it had withdrawn its approval for Umbralisib for the treatment of MZL and FL. Specifically, the FDA provided that “[u]updated results from the UNITY-CLL clinical trial continued to show an increased risk of death in patients receiving [UKONIQ]. Accordingly, we have determined the risks of treatment with [UKONIQ] outweigh its benefits.
On this news, TG “Therapeutics” stock price fell $0.51 per share, or 11.53%, to close at $3.91 per share on June 1, 2022.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris and Tel Aviv, is recognized as one of the leading firms in the areas of corporate litigation, securities and antitrust. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he established, fighting for the rights of victims of securities fraud, breaches of fiduciary duty and corporate misconduct. The firm recovered numerous multimillion-dollar damages on behalf of class members. See www.pomlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980