Tags:

TG Therapeutics, Inc. 


A securities class action has been filed against TG Therapeutics, Inc. (TGTX) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired TG Therapeutics securities between January 15, 2020 through May 31, 2022.  This case has been filed in the USDC – S.D.N.Y.

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Then, on April 15, 2022, TG Therapeutics issued a press release “announc[ing] that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib)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.

Tags:

Securities