Zai Lab Announces Margetuximab Achieved Primary Objective in Bridging Study in Advanced HER2+ Breast Cancer in Greater China
October 05, 2021 07:30 ET
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Zai Lab Limited
-- Demonstrated efficacy and safety consistent with global SOPHIA study-- Company expects to file BLA in China in advanced HER2+ breast cancer by approximately year end 2021 SHANGHAI and SAN...
MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021
September 16, 2021 02:45 ET
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MacroGenics, Inc.
21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A78% of patients had tumor...
MacroGenics Announces Final Overall Survival Results from SOPHIA Study of MARGENZA™ in Patients with HER2-Positive Metastatic Breast Cancer
September 07, 2021 16:30 ET
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MacroGenics, Inc.
Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumabOS was greater with MARGENZA plus chemotherapy in exploratory subgroups of...
MacroGenics Announces Presentations at the 2021 AACR Annual Meeting
April 10, 2021 08:30 ET
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MacroGenics, Inc.
ROCKVILLE, MD, April 10, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based...
MacroGenics Announces Publication of SOPHIA Trial Results for MARGENZA™ in JAMA Oncology
January 25, 2021 07:30 ET
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MacroGenics, Inc.
Primary endpoint of Phase 3 study met with MARGENZA (margetuximab-cmkb) showing a 24% Progression Free Survival (PFS) relative risk reduction compared to Herceptin® (trastuzumab), both with...
MacroGenics Announces FDA Approval of MARGENZA™ for Patients with Pretreated Metastatic HER2-Positive Breast Cancer
December 16, 2020 16:30 ET
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MacroGenics, Inc.
MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head...
MacroGenics and EVERSANA Announce Agreement to Support the Potential Launch and Commercialization of Margetuximab
November 30, 2020 16:30 ET
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MacroGenics, Inc.
MacroGenics accesses EVERSANA’s full suite of commercial services for which both parties share expensesEVERSANA may earn revenue share payments over five years subject to predefined capMacroGenics’...
MacroGenics Announces Lancet Oncology Publication of Margetuximab Data in Gastric Cancer
July 09, 2020 18:43 ET
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MacroGenics, Inc.
Rockville, MD, July 09, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal...
MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer
June 05, 2020 07:30 ET
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MacroGenics, Inc.
Rockville, MD, June 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal...
MacroGenics Provides Update on FDA Review of Margetuximab for HER2-Positive Metastatic Breast Cancer
May 28, 2020 07:30 ET
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MacroGenics, Inc.
- Advisory committee meeting not required; PDUFA goal date unchanged Rockville, MD, May 28, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical...