MacroGenics Secures $24.5M Milestone from Sanofi After FDA Approves TZIELD Stage 3 Pediatric T1D
MGNX•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.
1. FDA Approval and Milestone Payment
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.
2. Collaboration Terms and Future Payments
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.
3. TZIELD Indication and Global Expansion
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.
