TG Therapeutics, Inc.

  • Active

Investigation
04/18/2022

Initial Lawsuit
07/18/2022

Lawsuit Progression
09/16/2022

Investigation

  • Continous Holding
    January 15, 2020 to May 31, 2022
  • Proposed Claim
    Securities Violation

Did TG Therapeutics, Inc. (TGTX) mislead investors about the benefit-risk ratio of Ublituximab and Umbralisib?

Did the company mislead investors about the Umbralisib MZL/FL New Drug Application (NDA), the U2 Biologics License Applications (BLA), the Ublituximab RMS BLA or the U2 supplemental New Drug Application?

This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.

A lawsuit was subsequently filed. We will update this post as it unfolds.

Main Event

Application Withdrawal

04/15/2022

Company Statement

TG Therapeutics voluntarily withdraws the pending 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).

“The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS. . . In addition, the Company announced that it has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies.”

“Pursuant to a recent information request made by the FDA, updated OS data were collected that showed an increasing imbalance in favor of the control arm, differing from the improved results provided to the FDA in February 2022. Based on these new data, the Company decided to withdraw the pending BLA/sNDA for U2 to treat CLL/SLL and accordingly the April 22, 2022, ODAC meeting will be canceled.

In addition, based on the Company’s decision to withdraw UKONIQ from sale, we anticipate that the FDA will withdraw the accelerated approval for the product.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$6.92 $8.85 $-1.93 -21.81%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 07/18/2022

A TG Therapeutics, Inc. (TGTX) investor filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities (other than the defendants) that purchased or otherwise acquired TG Therapeutics securities between January 15, 2020, and May 31, 2022, both dates inclusive.

  • Filing Date
    07/18/2022
  • Class Period
    01/15/2020 to 05/31/2022
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
  • Case Title
    Shapiro v. TG Therapeutics, Inc. et al
  • Docket Number
    1:22-cv-06106
  • Court
    New York Southern District Court
  • Free File
    Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:

(i) clinical trials revealed significant concerns related to the benefit-risk ratio and overall survival data ofUblituximab and Umbralisib;
(ii) accordingly, it was unlikely that the company would be able to obtain FDA approval of the Umbralisib MZL/FL NDA, the U2 BLA, the U2 sNDA, or the Ublituximab RMS BLA in their current forms;
(iii) as a result, the company had significantly overstated Ublituximab and Umbralisib’s clinical and/or commercial prospects; and
(iv) therefore, the company’s public statements were materially false and misleading at all relevant times.

Defendants

  • Company
    TG Therapeutics, Inc.
  • Chief Executive Officer
    Michael S. Weiss
  • Chief Financial Officer
    Sean A. Power

Lawsuit progression

  • Docket Number
    1:22-cv-06106
  • Court
    New York Southern District Court

The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/26/2022.

[stockdio-historical-chart symbol=”TGTX” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

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