TG Therapeutics, Inc. (TGTX) 

Investigation 

Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of TG Therapeutics, Inc. (“TG Therapeutics” or the “Company”) (NASDAQ: TGTX). Investors who purchased TG Therapeutics shares are encouraged to obtain additional information and assist in the investigation.         

 

The investigation concerns whether TG Therapeutics and certain of its officers and/or directors have violated federal securities laws.

 

On November 30, 2021, TG Therapeutics issued a press release “announc[ing] the U.S. Food and Drug Administration (FDA) has notified the Company 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 chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).”  TG Therapeutics advised that “[t]he FDA has notified the Company 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 marginal zone lymphoma (MZL) or follicular lymphoma (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”, stating 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 $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  Then, on April 15, 2022, TG Therapeutics issued a press release “announc[ing] that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib)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 referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (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 $1.93 per share, or 21.81%, to close at $6.92 per share on April 18, 2022.  Finally, 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 the Company in response to an FDA information request, which the FDA deemed 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.

 

If you are aware of any facts relating to this investigation or purchased TG Therapeutics shares, you can assist this investigation. You can also contact Peretz Bronstein or his law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484. 

 

Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits.  The firm has recovered hundreds of millions of dollars for investors nationwide.  Attorney advertising. Prior results do not guarantee similar outcomes.