MacroGenics announced that it will receive a $24.5 million regulatory milestone payment from Sanofi following the FDA’s accelerated approval of TZIELD.
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.
MacroGenics said the approval expands the therapeutic potential of TZIELD as a disease-modifying therapy for type 1 diabetes.
Under the terms of MacroGenics’ agreement with Sanofi, the recent FDA approval triggered the $24.5 million regulatory milestone payable to MacroGenics.
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.
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.
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.
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.
