If you invested in TG Therapeutics and have significant losses, or have knowledge that may assist the firm's investigation, click here to discuss your legal rights with Hagens Berman. "We're focused on investors' losses and whether TG misrepresented safety data in connection with its submissions to the FDA," said Reed Kathrein, the Hagens Berman partner leading the investigation. These events drove the price of TG Therapeutics shares sharply lower. Finally, on Jthe FDA announced that it revoked approval for Umbralisib for treating MZL and FL due to safety concerns. Then, on ApTG announced it withdrew its U2 BLA/U2sNDA based on safety data. 30, 2021, when TG announced that the FDA planned to host a meeting of the Oncologic Drugs Advisory Committee in connection with its review of the U2 BLA and U2sNDA. Investors learned the truth through a series of partial disclosures beginning on Nov. The complaint alleges Defendants made false and misleading statements and/or failed to disclose material facts, including clinical trial data revealing significant concerns over the safety of Ublituximab and Umbralisib, making it unlikely that the FDA would approve the company's applications in their current forms. The litigation is focused on Defendants' statements about TG's (1) new drug application ("NDA") to the FDA requesting accelerated approval of Umbralisib for treating marginal zone lymphoma ("MZL") and follicular lymphoma ("FL"), (2) biologics license application ("BLA") to the FDA for Ublituximab in combination with Umbralisib (together, "U2") for treating patients with chronic lymphocytic leukemia ("CLL") (the "U2 BLA"), (3) supplemental NDA ("sNDA") for Umbralisib to add an indication for CLL and small lymphocytic lymphoma ("SLL") in combination with Ublituximab (the "U2 sNDA"), and (4) BLA for Ublituximab as a treatment for relapsing forms of multiple sclerosis (the "Ublituximab RMS BLA").
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