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MacroGenics Enters Into Agreement With TerSera Therapeutics for the Sale of MARGENZA®
ROCKVILLE, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)-- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing,
About this update from Macrogenics, Inc.
[{"type":"text","content":" ROCKVILLE, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)--\nMacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, and TerSera Therapeutics LLC, a privately-held biopharmaceutical company with a focus in oncology and non-opioid pain management, announced today that they have entered into an agreement in which TerSera will acquire global rights to MARGENZA® (margetuximab-cmkb).\n\nMARGENZA was approved by the U.S. Food and Drug Administration (FDA) in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on results from the pivotal Phase 3 head-to-head clinical trial (SOPHIA) evaluating the safety and efficacy of MARGENZA vs. Herceptin® (trastuzumab), both combined with chemotherapy.\n\nPursuant to the terms of the agreement, TerSera will pay MacroGenics $40 million at closing. MacroGenics may receive additional sales milestone payments of up to an aggregate of $35 million. The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions.\n\n“This transaction will enable us to focus our efforts on advancing our pipeline of novel and differentiated oncology product candidates,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “We believe TerSera’s established and complementary U.S. commercial infrastructure has the potential to broaden patient access to MARGENZA.”\n\n“MARGENZA is an important treatment option for patients with metastatic HER2+ breast cancer,” said Edward Donovan, Chief Executive Officer of TerSera. “We are very excited to add MARGENZA to our existing oncology portfolio, deepening our commitment to the treatment of patients with breast cancer.”\n\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY\n\n\nLeft Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ve...