TG THERAPEUTICS, INC. (NASDAQ: TGTX) SHAREHOLDER CLASS
Have you lost money on your investments in TG Therapeutics? If so, please visit TG Therapeutics, Inc. Shareholder Class Action or contact Pierre Allocco at (212) 951-2030 or email@example.com to discuss your rights.
NEW YORK, July 19. 12, 2022 (GLOBE NEWSWIRE) — Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of TG Therapeutics, Inc. (“TG Therapeutics” or the “Company”). ) (NASDAQ: TGTX) between January 15, 2020 and May 31, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of New York and alleges violations of the Securities Exchange Act of 1934.
TG Therapeutics is a commercial-stage biopharmaceutical company. Its therapeutic product candidates include Ublituximab, an investigational glycoengineered 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”).
Plaintiff alleges that Defendants made materially false and misleading statements throughout the Class Period. Specifically, Plaintiff alleges that Defendants 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; and (iii) as a result, the Company had significantly overestimated the clinical and/or commercial prospects of Ublituximab and Umbralisib.
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.
If you wish to act as the main plaintiff, you must apply to the court no later than September 16, 2022. A lead plaintiff is a representative party acting on behalf of other class members to direct litigation. Your ability to participate in any recovery does not require you to serve as the primary plaintiff. If you choose to do nothing, you can remain an absent member of the group.
If you purchased securities of TG Therapeutics and/or wish to discuss your legal rights and options please visit TG Therapeutics, Inc. Shareholder Class Action or contact Pierre Allocco at (212) 951-2030 or firstname.lastname@example.org.
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