TG Therapeutics, Inc. (NASDAQ:TGTX) Files An 8-K Other Events
Item 8.01. Other Events.
On January 22, 2019, TG Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 regimen. A copy of the press release is being filed as Exhibit 99.1 and incorporated in this Item by reference.
Item 9.01 Financial Statements And Exhibits.
(d) Exhibits.
99.1 Press Release, dated January 22, 2019
TG THERAPEUTICS, INC. Exhibit
EX-99.1 2 v012219_ex991.htm EXHIBIT 99.1 Untitled Document Exhibit 99.1 TG Therapeutics Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma Breakthrough Therapy Designation granted based on interim data from the Marginal Zone Lymphoma cohort of the UNITY-NHL trial NEW YORK,…
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About TG Therapeutics, Inc. (NASDAQ:TGTX)
TG Therapeutics, Inc. (TG) is a biopharmaceutical company focused on the acquisition, development and commercialization of treatments for b-cell malignancies and autoimmune diseases. The Company is developing over two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a glycoengineered monoclonal antibody that targets a specific epitope on the CD20 antigen found on mature B-lymphocytes. The Company is also developing TGR-1202, an orally available Phosphoinositide 3-kinase (PI3K) delta inhibitor. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has pre-clinical programs focusing on developing interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors and anti-PD-L1 and anti-GITR antibodies. The Company also evaluates complementary products, technologies and companies for in-licensing, partnership, acquisition and investment opportunities.
