Overview
MacroGenics Inc (NASDAQ:MGNX) saw its shares increase 1.3% in after‑hours trading on Monday after the company announced that Sanofi will make a $24.5 million regulatory milestone payment.
Milestone Payment Details
The payment is triggered by the U.S. Food and Drug Administration’s accelerated approval of TZIELD (teplizumab‑mzwv) for use in children aged eight to 17 years who have been recently diagnosed with stage 3 type 1 diabetes. The approval expands TZIELD’s therapeutic potential as a disease‑modifying therapy for type 1 diabetes.
Under the existing collaboration agreement, MacroGenics remains eligible to receive up to $305 million in additional milestone payments. The agreement also grants MacroGenics a right to a single‑digit royalty on global net sales of TZIELD that exceed a specified annual sales threshold.
TZIELD Approvals
TZIELD is a CD3‑directed monoclonal antibody and is the first disease‑modifying therapy for autoimmune type 1 diabetes. It was initially approved in the United States in November 2022 for delaying the onset of stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 disease. Subsequent approvals have been obtained in the United Kingdom, the European Union, China, Australia, Canada, Israel, Saudi Arabia, the United Arab Emirates, Kuwait, Brazil and Switzerland for adults and children eight years and older with stage 2 type 1 diabetes.
Company Profile
MacroGenics is a clinical‑stage biopharmaceutical company focused on developing antibody‑based therapeutics for the treatment of cancer.