MacroGenics Inc. (MGNX)

[XenaLives]

Nov 17, 2022
MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab
ROCKVILLE, MD, Nov. 17, 2022 (GLOBE NEWSWIRE) --

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that the U.S. Food and Drug Administration announced the approval of the Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody that was previously developed by MacroGenics. Teplizumab was acquired by Provention Bio, Inc. in May 2018 pursuant to an asset purchase agreement.

“We are very pleased to see the culmination of years of effort by Provention, MacroGenics, and tireless champions in academia and government, with the achievement of the approval of teplizumab,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We applaud this outcome, which represents an advancement for individuals and their families dealing with the risks and consequences of type 1 diabetes.”

Under the agreement, Provention is obligated to pay MacroGenics contingent milestone payments totaling $170 million upon the achievement of certain regulatory approval milestones, including $60 million for the approval of a BLA for a first indication in the United States. In addition, Provention is obligated to make contingent milestone payments to MacroGenics totaling $225 million upon the achievement of certain sales milestones as well as a single-digit royalty on net sales of the product.

Based on MacroGenics’ cash, cash equivalents and marketable securities balance as of September 30, 2022, plus projected and anticipated payments from partners, including timely receipt of the milestone payment from Provention, MacroGenics currently anticipates having a cash runway into late 2024.

https://www.globenewswire.com/news-release/2022/11/17/2558767/0/en/MacroGenics-Earns-60-Million-Milestone-with-U-S-FDA-Approval-of-Teplizumab.html