TG Therapeutics, Inc. (TGTX) Overstated the Clinical and Commercial Prospects of its New Drugs
A shareholder filed a class action on behalf of all persons who purchased or otherwise acquired TG Therapeutics, Inc. (NASDAQ: TGTX) securities between January 15, 2020 and May 13, 2022, for violations of the Securities Exchange Act of 1934. TG Therapeutics is a commercial stage biopharmaceutical company. The Company’s 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 (“MZL”), and follicular lymphoma (“FL”).
According to the complaint, in January 2020, TG Therapeutics initiated a rolling submission of a New Drug Application (“NDA”) to the FDA, requesting accelerated approval of Umbralisib as a treatment for patients with previously treated MZL and FL (the “Umbralisib MZL/FL NDA). In December 2020, the Company initiated a rolling submission of a Biologics License Application (“BLA”) to the FDA for Ublituximab in combination with Umbralisib as a treatment for patients with CLL (the “U2 BLA”).
In May 2021, TG Therapeutics submitted a supplemental NDA (“sNDA”) for Umbralisib to add an indication for CLL and small lymphocytic lymphoma (“SLL”) in combination with Ublituximab (the “U2 sNDA”). In September 2021, TG Therapeutics submitted a BLA for Ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (“RMS”) (the “Ublituximab RMS BLA”).
Then, on November 20, 2021, TG Therapeutics advised that the FDA was evaluating “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 the FDA’s concern “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 almost 35%, to close at $15.20 per share on November 30, 2021.
On April 15, 2022, TG Therapeutics announced it had “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.
Then, on May 31, 2022, TG Therapeutics announced 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.
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 $0.51 per share, or 11.53%, to close at $3.91 per share on June 1, 2022.
Next Steps: If you acquired shares of TG Therapeutics, Inc. (TGTX) securities between January 15, 2020 and May 13, 2022, you have until September 16, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.