Everything You Need to Know about the TG Therapeutics, Inc. Class Action Lawsuit

8/12/2022

The TG Therapeutics class action lawsuit seeks to represent purchasers or acquirers of TG Therapeutics, Inc. (NASDAQ: TGTX) securities between January 15, 2020 and May 31, 2022, inclusive (the “Class Period”). The TG Therapeutics class action lawsuit – captioned Shapiro v. TG Therapeutics, Inc., No. 22-cv-06106 (S.D.N.Y.) – charges TG Therapeutics and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered losses in TG Therapeutics stock and wish to serve as lead plaintiff of the TG Therapeutics class action lawsuit, please provide your information below. You can also contact TG Therapeutics Stock Loss Lawyer Timothy L. Miles by calling 855/846-6529 or via e-mail at tmiles@timmileslaw.com. Lead plaintiff motions for the TG Therapeutics class action lawsuit must be filed with the court no later than September 16, 2022. If you suffered losses in TG Therapeutics and have questions, please contact TG Therapeutics Stock Loss Lawyer Timothy L. Miles today.

Allegations in the TG Therapeutics Class Action Lawsuit

TG Therapeutics’ therapeutic product candidates include Ublituximab, an investigational glycoengineered monoclonal antibody for the treatment of B-cell Non-Hodgkin lymphoma, chronic lymphocytic leukemia (“CLL”), and relapsing forms of multiple sclerosis; and Umbralisib, or UKONIQ, an oral inhibitor of PI3K-delta and CK1-epsilon for the treatment of CLL, marginal zone lymphoma, and follicular lymphoma. In January 2020, TG Therapeutics initiated a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”), requesting accelerated 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 rolling submission of a Biologics License Application (“BLA”) 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 “U2 sNDA”). And 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 TG Therapeutics class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and 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) accordingly, it was unlikely that TG Therapeutics 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; and (iii) as a result, TG Therapeutics had significantly overstated Ublituximab and Umbralisib’s clinical and/or commercial prospects.

On November 30, 2021, TG Therapeutics issued a press release “announc[ing] the [FDA] has notified [TG Therapeutics] that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of 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 [CLL] and [SLL].” TG Therapeutics advised that “[t]he FDA has notified [TG Therapeutics] that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory [MZL] or [FL]. In addition, 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, is expected to be reviewed.” The release also stated that “[t]he FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.” On this news, TG Therapeutics’ stock price fell by nearly 35%.

Then, on April 15, 2022, TG Therapeutics issued a press release “announc[ing] that [TG Therapeutics] has voluntarily withdrawn the pending [BLA)/sNDA] for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with [CLL] and [SLL].” The press release stated that “[t]he 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.” On this news, TG Therapeutics’ stock price fell by nearly 22%.

Thereafter, on May 31, 2022, TG Therapeutics issued a press release announcing that the FDA extended the Prescription Drug User Fee Act date for Ublituximab to December 28, 2022 “to allow time to review a submission provided by [TG Therapeutics] in response to an FDA information request, which the FDA deemed a major amendment.” On this news, TG Therapeutics’ stock price fell by more than 14%, and investors suffered losses in TG Therapeutics stock.

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]pdated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving [UKONIQ]. As a result, we determined the risks of treatment with [UKONIQ] outweigh its benefits.” On this news, TG Therapeutics’ stock price fell by an additional 11.5%, further damaging investors who suffered losses in TG Therapeutics stock. If you suffered losses in TG Therapeutics stock, contact TG Therapeutics Stock Loss Lawyer Timothy L. Miles.

The Lead Plaintiff Process in the TG Therapeutics Class Action Lawsuit

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased and suffered losses in TG Therapeutics to seek appointment as lead plaintiff in the TG Therapeutics class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the class action lawsuit. An investor’s ability to share in any potential future recovery of the class action lawsuit is not dependent upon serving as lead plaintiff. If you suffered losses in TG Therapeutics stock, and have further questions, contact TG Therapeutics Stock Loss Lawyer Timothy L. Miles today.

Contact a TG Therapeutics Stock Loss Lawyer if You Suffered Losses in TG Therapeutics

If you suffered losses in TG Therapeutics stock, contact TG Therapeutics Stock Loss Lawyer Timothy L. Miles today about a TG Therapeutics class action lawsuit, and see what a TG Therapeutics Stock Loss Lawyer can do for you.

Timothy L. Miles, Esq.

T imothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Mr. Miles was recentely selected by Martindale-Hubbell® and ALM as a 2022 Top Ranked Lawyer, 2022 Top Rated Litigator. and a 2022 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, and more.

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