SAN FRANCISCO, Sept. 12, 2022 (GLOBE NEWSWIRE) — Hagens Berman is urging TG Therapeutics, Inc. (NASDAQ:TGTX) Investors who have suffered significant losses Submit your losses now. A class action lawsuit alleging securities fraud has been filed.

TG Therapeutics, Inc. (NASDAQ: TGTX) Securities Class Action:

The litigation focuses on Defendants’ statements regarding Defendants’ (1) New Drug Application (“NDA”) with the FDA seeking accelerated approval of umbralisib for the treatment of marginal zone lymphoma (“MZL”) and follicular Lymphoma (“FL”), (2 ) Biologics License Application (“BLA”) with the FDA for ubituximab in combination with umbralisib (collectively “U2”) for the treatment of patients with chronic lymphocytic leukemia (“CLL”) (das “U2 BLA”), (3) supplemental NDA (“sNDA”) for umbralisib to add an indication for CLL and small lymphocytic lymphoma (“SLL”) in combination with ubituximab (the “U2 sNDA”), and (4) BLA for ubituximab for the treatment of relapsing forms of multiple sclerosis (the “Ublituximab RMS BLA”).

The complaint alleges that the defendants made false and misleading statements and/or failed to disclose material facts, including clinical trial data, that revealed significant safety concerns about ubituximab and umbralisib, making it unlikely that the FDA would approve the company’s applications would approve in its current form.

Investors learned the truth through a series of partial disclosures that began on November 30, 2021, when TG announced that the FDA plans to host an Oncology Drug Advisory Committee meeting in connection with its review of the U2 BLA and U2sNDA. Then, on April 15, 2022, TG announced that it had withdrawn its U2 BLA/U2sNDA based on safety data. Finally, on June 1, 2022, the FDA announced that it had withdrawn approval of umbralisib for the treatment of MZL and FL due to safety concerns.

These events drove the price of TG Therapeutics shares down sharply.

“We are focused on investors’ losses and whether TG has the safety data in…