TG Therapeutics, Inc. (NASDAQ:TGTX) Files An 8-K Other EventsItem 8.01. Other Events.
On August 1, 2017, TG Therapeutics, Inc. (the “Company”) issued a press release announcing it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), the Company’s glycoengineered anti-CD20 monoclonal antibody, for the treatment of relapsing forms of Multiple Sclerosis (RMS). A copy of the press release is being filed as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements And Exhibits.
(d) Exhibits.
99.1 Press Release, dated August 1, 2017.
TG THERAPEUTICS, INC. ExhibitEX-99.1 2 v080117_ex991.htm EXHIBIT 99.1 Blueprint TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement with the FDA for a Phase 3 Program of TG-1101 (ublituximab) for Patients with Multiple Sclerosis (MS) Global Phase 3 Program Expected to Commence Before End of Q3 2017 International Phase 3 Trials Entitled “ULTIMATE I” and “ULTIMATE II” to be Led by Lawrence Steinman,…To view the full exhibit click here
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.