The Law Offices of Timothy L. Miles Reminds Investors of a Lawsuit Against TG Therapeutics, Inc.

Nationally Recognized Shareholder Rights Attorney Timothy L. MIles

Nationally Recognized Shareholders Rights Attorney Timothy L. Miles

Timothy L. Miles, a nationally acknowledged shareholder rights lawyer

Nationally Recognized Shareholder Rights Attorney Timothy L. Miles Has Achieved the Recognition of American’s Mo

Nationally Recognized Shareholder Rights Attorney Timothy L. MIles

Class motion lawsuit fees TG Therapeutics and sure of its high government officers with violations of the Securities Exchange Act of 1934.

TG Therapeutics, Inc. (NASDAQ:TGTX)

NASHVILLE, TENNESSEE, UNITED STATES, September 9, 2022 /EINPresswire.com/ — The Law Offices of Timothy L. Miles, who has been main the struggle to guard shareholder rights for over 20 years, reminds buyers that a that a purchaser of TG Therapeutics, Inc. (NASDAQ: TGTX) who suffered losses in TG Therapeutics, filed a class motion criticism towards the Company for alleged violations of the Securities Exchange Act of 1934. The TG Therapeutics class motion lawsuit seeks to characterize purchasers or acquirers of TG Therapeutics securities between January 15, 2020 and May 31, 2022, inclusive (the “Class Period”). The TG Therapeutics class motion lawsuit is captioned Shapiro v. TG Therapeutics, Inc., No. 22-cv-06106 (S.D.N.Y.).

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Allegations within the TG Therapeutics Class Action Lawsuit

TG Therapeutics’ therapeutic product candidates embody Ublituximab, an investigational glycoengineered monoclonal antibody for the therapy of B-cell Non-Hodgkin lymphoma, persistent lymphocytic leukemia (“CLL”), and relapsing types of a number of sclerosis; and Umbralisib, or UKONIQ, an oral inhibitor of PI3K-delta and CK1-epsilon for the therapy 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 therapy for sufferers with beforehand handled 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 together with Umbralisib (collectively, “U2”), as a therapy for sufferers with CLL (the “U2 BLA”). In May 2021, TG Therapeutics submitted a supplemental New Drug Application (“sNDA”) for Umbralisib so as to add a sign for CLL and small lymphocytic lymphoma (“SLL”) together with Ublituximab (the “U2 sNDA”). And in September 2021, TG Therapeutics submitted a BLA to the FDA for Ublituximab as a therapy for sufferers with relapsing types of a number of sclerosis (“RMS”) (the “Ublituximab RMS BLA”).

The TG Therapeutics class motion lawsuit alleges that, all through the Class Period, defendants made false and deceptive statements and didn’t disclose that: (i) scientific trials revealed vital considerations associated to the benefit-risk ratio and total survival information of Ublituximab and Umbralisib; (ii) accordingly, it was unlikely that TG Therapeutics would be capable of receive FDA approval of the Umbralisib MZL/FL NDA, the U2 BLA, the U2 sNDA, or the Ublituximab RMS BLA of their present types; and (iii) as a outcome, TG Therapeutics had considerably overstated Ublituximab and Umbralisib’s scientific and/or business prospects.

On November 30, 2021, TG Therapeutics issued a press launch “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 suggested 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 launch additionally acknowledged 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 information, TG Therapeutics’ inventory worth fell by almost 35%.

Then, on April 15, 2022, TG Therapeutics issued a press launch “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 launch acknowledged 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 information, TG Therapeutics’ inventory worth fell by almost 22%.

Thereafter, on May 31, 2022, TG Therapeutics issued a press launch asserting that the FDA prolonged 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 information, TG Therapeutics’ inventory worth fell by greater than 14%.

Finally, on June 1, 2022, the FDA introduced that, because of security considerations, it had withdrawn its approval for Umbralisib for the therapy of MZL and FL. Specifically, the FDA supplied 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 information, TG Therapeutics’ inventory worth fell by an extra 11.5%, additional damaging buyers who suffered losses in TG Therapeutics inventory.

TG Therapeutics Shareholders Urged to Contact the Firm

If you bought TG Therapeutics securities, have info, or have any questions regarding this announcement or your rights or pursuits with respect to those issues, please click on right here for extra info or contact Timothy L. Miles, Esquire, at 615-587-7384, Toll-Free at 855-846-6529, or by e-mail to [email protected]. If you inquire by e-mail please embody your mailing handle, phone quantity, and the quantity shares owned.

About Timothy L. Miles

Timothy L. Miles is a nationally acknowledged shareholder rights lawyer raised in Nashville, Tennessee. Mr. Miles was recentely chosen by Martindale-Hubbell^® and ALM as a 2022 Top Ranked Lawyer and a 2022 Top Rated Litigator. Mr. Miles additionally maintains the AV Preeminent Rating by Martindale-Hubbell^®, their highest ranking for each authorized means and ethics. Mr. Miles is a member of the distinguished Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a very good rated lawyer by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and acknowledged as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019).

Awards: Top Rated Litigator by Martindale-Hubbell^® and ALM (2019); 2019 Elite Lawyer of The South by Martindale-Hubbell^® and ALM (2019); Member of the Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association (2017-2019); AV^® Preeminent™ Rating by Martindale-Hubble^® (2014-2020); PRR AV Preeminent Rating on Lawyers.com (2017 & 2019); The Top-Rated Lawyer in Litigation™ for Ethical Standards and Legal Ability (Martindale-Hubble^® 2015); Lifetime Achievement Award by Premier Lawyers of America (2019); Superb Rated Attorney (Avvo); Avvo Top Rated Lawyer for (Avvo 2017-2020). Mr. Miles has authored quite a few publications advocating for shareholdings together with most not too long ago: Free Portfolio Monitoring Services Offered by Plaintiff Securities Firms Provides Significant Benefits To Investors (Timothy L. Miles, Dec. 3, 2019).

Contact:

Timothy L. Miles, Esq.

Law Offices of Timothy L. Miles

109 Summit Ridge Ct.

Nashville, TN 37215

Telephone: (855-846-6529)

Email: [email protected] Website: www.classactionlawyertn.com

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