MacroGenics to receive $24.5M milestone from Sanofi on FDA approval

MacroGenics, Inc. (NASDAQ: MGNX) announced it will receive a $24.5 million regulatory milestone payment from Sanofi following the U.S. Food and Drug Administration's accelerated approval of TZIELD® (teplizumab-mzwv) for a new indication in pediatric patients.

The FDA approved TZIELD to delay the decline in endogenous insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes. The approval triggered the milestone payment under the terms of MacroGenics' existing agreement with Sanofi.

Under that agreement, MacroGenics remains eligible to receive up to $305 million in additional milestone payments and retains the right to receive a single-digit royalty on global net sales above a specified annual threshold.

TZIELD 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 that indication to include children aged one year and above. In June 2026, the FDA also approved TZIELD to delay the onset of stage 3 type 1 diabetes in adults.

The drug is approved in multiple additional markets, including the UK, EU, China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil, and Switzerland.

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