MacroGenics will receive a $24.5 million Sanofi milestone payment after FDA accelerated approval of TZIELD for stage 3 type 1 diabetes in children aged eight to 17. Under that deal, they remain eligible for up to $305 million more and single-digit royalties on sales above a threshold.
The U.S. Food and Drug Administration granted accelerated approval for TZIELD to delay the decline of endogenous insulin production in children aged eight to 17 with stage 3 type 1 diabetes, triggering a $24.5 million regulatory milestone payment to MacroGenics from Sanofi.
Under the existing Sanofi collaboration, MacroGenics can receive up to $305 million in additional milestone payments tied to regulatory and commercial achievements, and retains the right to a single-digit royalty on TZIELD global sales above a specified annual threshold.
TZIELD is the first disease-modifying monoclonal antibody therapy for autoimmune type 1 diabetes, initially approved in November 2022 for stage 2 disease and subsequently expanded to pediatric stage 2 and adult stage 3 in April and June 2026, with approvals also secured in the UK, EU, China and multiple other countries.
