MACROGENICS, INC. (NASDAQ:MGNX) Files An 8-K Other EventsItem 8.01. Other Events.
On December 7, 2018, the Company issued a press release announcing that the U.S. Food and Drug Administration has placed a partial clinical hold on its Phase 1 monotherapy study of MGD009, a B7-H3 × CD3 bispecific DART® molecule as well as on a combination study of MGD009 and MGA012 (anti-PD-1). 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
(d) Exhibits.
MACROGENICS INC ExhibitEX-99.1 2 fdamgd0092018-12x07final.htm EXHIBIT 99.1 Exhibit MacroGenics Announces Partial Clinical Hold on MGD009 Phase 1 StudiesROCKVILLE,…To view the full exhibit click here
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.