MGNX News & Events

MacroGenics (MGNX) announced that it will receive a $24.5M regulatory milestone payment from Sanofi (SNY) following the U.S. Food and Drug Administration's accelerated approval of 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 expands the therapeutic potential of TZIELD as a disease-modifying therapy for type 1 diabetes. Under the terms of MacroGenics' agreement with Sanofi, the recent FDA approval triggered a $24.5M regulatory milestone payable to MacroGenics. The Company remains eligible to receive up to $305M in additional milestone payments and retains the right to receive a single-digit royalty on global net sales above a specified annual threshold.

Reports Q1 revenue $20.78M, consensus $15.24M. "We are very pleased to report a strong start to the year, building on the momentum generated in 2025. These results reflect our team's disciplined execution of a strategy designed to sharpen our focus, maximize the value of our pipeline, and strengthen our financial position. As part of this effort, we recently announced the sale of our GMP manufacturing operations to Bora Pharmaceuticals and the monetization of additional ZYNYZ royalties with Sagard Healthcare Partners. Subject to the closing of the manufacturing operations divestiture, these transactions are expected to provide significant non-dilutive capital to support growth opportunities in 2026 and beyond," said Eric Risser, President and CEO of MacroGenics. "We look forward to providing multiple updates during the remainder of the year, including key programmatic milestones for MGC026, MGC028, and MGC030. We believe our increased focus on discovering and developing breakthrough medicines has the potential to enhance patients' lives while creating meaningful value for our shareholders."

MacroGenics and Bora Pharmaceuticals announced that they had entered into a definitive agreement in which MacroGenics will sell its good manufacturing practice, or GMP, drug substance manufacturing operations to Bora, subject to customary closing conditions. Under the terms of the asset purchase agreement, Bora will pay MacroGenics an upfront payment of $122.5M, before transaction fees and expenses. Upon closing, Bora will assume responsibility for MacroGenics' manufacturing operations supporting clinical and commercial production. Both the Rockville, Maryland headquarters site, including the FDA-approved facility with total capacity of 11,000 liters, and Frederick, Maryland warehouse will transfer to Bora. In addition, approximately 140 MacroGenics employees are expected to be hired by Bora. The companies will jointly work to ensure a transition and continued service for both MacroGenics and any existing CDMO client. As part of the transaction, MacroGenics will have a supply arrangement with Bora to support process development and drug substance production for its internal pipeline needs. The transaction is expected to close in the third quarter of 2026, subject to the satisfaction or waiver of customary closing conditions.