Shareholder rights law firm Robbins LLP is investigating TG Therapeutics, Inc. (NASDAQ: TGTX) and its officers and directors to determine whether they breached their fiduciary duties or violated securities laws in overstating the clinical and commercial prospects of its new drugs. TG Therapeutics is a commercial stage biopharmaceutical company.
If you would like more information about our investigation of TG Therapeutics, Inc.'s misconduct, click here.
What is this Case About: According to the complaint filed against TG Therapeutics, in January 2020, the Company initiated a rolling submission of a New Drug Application ("NDA") to the FDA, requesting accelerated approval of Umbralisib (a/k/a UKONIO) as a treatment for patients with previously treated marginal zone lymphoma ("MZL") and follicular lymphoma ("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 chronic lymphocytic leukemia 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On April 15, 2022, TG Therapeutics announced it had "voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib)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 legal rights. Contact Robbins LLP for more information.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
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About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. To be notified if a class action against TG Therapeutics, Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today.
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