MacroGenics announced that it will receive a $24.5 million regulatory milestone payment from Sanofi following the FDA\u2019s accelerated approval of TZIELD.<\/p>\n
The approval covers TZIELD for delaying the decline in endogenous insulin production in children aged eight to 17 years who were recently diagnosed with stage 3 type 1 diabetes.<\/p>\n
MacroGenics said the approval expands the therapeutic potential of TZIELD as a disease-modifying therapy for type 1 diabetes.<\/p>\n
Under the terms of MacroGenics\u2019 agreement with Sanofi, the recent FDA approval triggered the $24.5 million regulatory milestone payable to MacroGenics.<\/p>\n
MacroGenics remains eligible to receive up to $305 million in additional milestone payments. The company also retains the right to receive a single-digit royalty on global net sales above a specified annual threshold.<\/p>\n
TZIELD, also known as teplizumab, is a CD3-directed monoclonal antibody. It was first approved in the U.S. in November 2022 to delay the onset of stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 type 1 diabetes.<\/p>\n
In April 2026, the FDA expanded the indication to include children aged one year and older. TZIELD is also approved in adults and children eight years and older with stage 2 type 1 diabetes in several international markets.<\/p>\n
MacroGenics is a clinical-stage biopharmaceutical company focused on developing antibody-based therapeutics for the treatment of cancer. The company develops product candidates through its proprietary antibody-based technology platforms and has entered into several strategic collaborations with global pharmaceutical and biotechnology companies.<\/p>\n
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