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NEW YORK, December 04, 2021--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against TG Therapeutics, Inc. ("TG Therapeutics" or the "Company") (NASDAQ: TGTX) on behalf of TG Therapeutics stockholders. Our investigation concerns whether TG Therapeutics has violated the federal securities laws and/or engaged in other unlawful business practices.
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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 FD’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.
If you purchased or otherwise acquired TG Therapeutics shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Alexandra B. Raymond by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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