New York-based TG Therapeutics voluntarily withdrew its pending Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for its combination of ublituximab and Ukoniq (umbralisib), dubbed U2, for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). The administration is continuing to evaluate results from the UNITY clinical trial, determining that “initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine.”
A not-so-funny thing happened to TG Therapeutics on its way to the accommodation review for its lead drug. The CEO revealed at an investment conference today that the FDA has slapped a hold over a segment of the R&D work it’s doing on the drug — a piece of the clinical plan that spurred some second looks after the hazard ratio made the drug look more dangerous than the comparator.
NEW YORK, Sept. 23, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from an integrated safety analysis of UKONIQ® (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory lymphoid malignancies in Blood Advances, a journal of the American Society of Hematology.
TG Therapeutics announced that the company has initiated a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) requesting approval of ublituximab, the company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL).
NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of data from a Phase 2 study evaluating umbralisib, the Company’s investigational once daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology.
NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of data from a Phase 2 study evaluating umbralisib, the Company’s investigational once daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology.
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021.
TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the 25th European Hematology Association (EHA) annual congress including data from a Phase 1 study evaluating TG-1701, the Company’s once daily, selective, BTK inhibitor, as monotherapy and in combination with umbralisib and ublituximab (U2) in relapsed/refractory chronic lymphocytic leukemia (CLL) and lymphoma, as well as long term data from a Phase 1/1b study evaluating the combination of umbralisib and ibrutinib in relapsed/refractory CLL and mantle cell lymphoma (MCL).