MacroGenics To Receive $24.5 Mln Milestone Payment From Sanofi For Recent TZIELD Approval

(RTTNews) - MacroGenics, Inc. (MGNX), a clinical-stage biopharmaceutical company, announced that it will receive a $24.5 million regulatory milestone payment from Sanofi following the recently granted U.S. Food and Drug Administration's (FDA) accelerated approval of TZIELD (teplizumab-mzwv) for children aged 8 to 17 years with recently diagnosed stage 3 type 1 diabetes or TID.

TZIELD is a CD3-directed monoclonal antibody indicated to slow the decline of endogenous insulin production.

MacroGenics originally developed TZIELD and later transferred commercial rights via licensing transactions with a partner that was later acquired by Sanofi. Under the agreement, MacroGenics retains rights to receive regulatory milestones and single-digit royalties on global sales following Sanofi's ownership of the asset.

In June 2026, the US Food and Drug Administration (FDA) granted accelerated approval to Tzield for use in children aged 8-17 years who were recently diagnosed with Stage 3 T1D, based on data from the PROTECT Phase 3 study demonstrating a slowed decline in endogenous insulin production.

Meanwhile, under the terms of MacroGenics' agreement with Sanofi, the recent FDA approval triggered a $24.5 million regulatory milestone payable to MacroGenics.

In addition, the company 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.

In November 2022, TZIELD was approved to delay progression to Stage 3 T1D in patients aged 8 years and older with Stage 2 T1D. In April 2026, the FDA expanded the indication to include patients as young as 1 year of age with Stage 2 T1D.

MGNX has traded between $1.18 and $4.64 over the last year. The stock closed Monday's trade at $4.58, up 10.90%.

In the pre-market, MGNX is trading at $4.67, up 1.97%.

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