MACROGENICS, INC. (NASDAQ:MGNX) Files An 8-K Other Events
Item 8.01. Other Events.
On January 25, 2019, the Company issued a press release announcing that the U.S. Food and Drug Administration has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 x CD3 bispecific DART® molecule. A copy of the press release (“the Press Release”) is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
MACROGENICS INC Exhibit
EX-99.1 2 mgd009clinicalholdlifted_p.htm EXHIBIT 99.1 Exhibit MacroGenics Announces Removal of Partial Clinical Hold on MGD009 Program by FDAROCKVILLE,…
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About MACROGENICS, INC. (NASDAQ:MGNX)
MacroGenics, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing monoclonal antibody-based therapeutics for the treatment of cancer, as well as various autoimmune disorders and infectious diseases. The Company operates through developing monoclonal antibody-based therapeutics for cancer, autoimmune and infectious diseases segment. It develops therapeutic product candidates using its antibody-based technology platforms and in partnership with other biopharmaceutical companies. It has a pipeline of product candidates in human clinical testing, primarily against various cancers. Its product candidates include margetuximab, enoblituzumab, MGD006, MGD007, MGD011, MGD009, MGD013, MGD010, teplizumab and MGD014. Its clinical product candidate, margetuximab, is a monoclonal antibody directed against human epidermal growth factor receptor 2, (HER2), including certain types of breast and gastroesophageal cancers.