Business
MacroGenics Provides Update on Corporate Progress and Third Quarter 2020 Financial Results
Conference call scheduled for today at 4:30 p.m. ET. ROCKVILLE, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage
About this update from Macrogenics, Inc.
[{"type":"text","content":"Conference call scheduled for today at 4:30 p.m. ET.\nROCKVILLE, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2020.\n “MacroGenics continued the advancement of its portfolio of multiple clinical molecules during the third quarter of 2020, with three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab. The PDUFA action date for margetuximab in breast cancer is December 18. Just prior, we look forward to our next presentation of flotetuzumab clinical data at ASH in December, following the publication of data in three separate journals this year highlighting the medical and scientific interest in this DART® molecule,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. \"At ESMO in September, we and our partner, Incyte, presented clinical data on MGD019 and retifanlimab, respectively. And on the heels of MGC018 data presented at ASCO, we recently commenced the enrollment of patients with mCRPC, TNBC and NSCLC. More near-term, we look forward to providing an update on tebotelimab plus margetuximab in HER2-positive patients at the upcoming SITC Annual Meeting this month. Finally, we look forward to updating you on continued progress through the rest of 2020 and into 2021.” Key Highlights from Investigational Product Candidates in Pivotal Studies: Margetuximab (Fc-engineered, anti-HER2 mAb): A Biologics License Application (BLA) for margetuximab, in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer, is being reviewed by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020. Based on the current accrual rate of overall survival (OS) events in the Phase 3 SOPHIA study, MacroGenics now anticipates accrual of the 385th OS event, which triggers the final OS analysis, in the second half of 2021.Enrollment of the global Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for pat...