Shares of MacroGenics Inc. (NASDAQ: MGNX) increased 6.25% to $6.97 on Thursday after the company reached a critical regulatory clearance milestone.
What does this achievement entail for MGNX?
Teplizumab, an anti-CD3 monoclonal antibody that was previously created by MacroGenics, received approval of the Biologics License Application (BLA) from the U.S. Food and Drug Administration, according to MacroGenics (MGNX). Provention Bio, Inc. acquired teplizumab in May 2018 thanks to an asset acquisition deal.
Teplizumab’s clearance is the culmination of years of work by Provention, MacroGenics, and devoted advocates in government and academia. MGNX was pleased with the conclusion, which signifies progress for those living with type 1 diabetes and their families who must deal with its risks and complications.
Financial benefits to MGNX:
A total of $170 million in contingent milestone payments totaling $170 million are due from Provention to MGNX under the terms of the agreement, including $60 million for the approval of a BLA for a first indication in the United States. Additionally, Provention is required to pay a single-digit royalty on the product’s net sales as well as contingent milestone payments to MGNX totaling $225 million upon the completion of specific sales milestones.
Based on MacroGenics’ balance of cash, cash equivalents, and marketable securities as of September 30, 2022, in addition to projected and anticipated payments from partners, including timely receipt of the milestone payment from Provention, MGNX currently believes it will have a cash runway into late 2024.
A MGNX update:
Additionally this month, MacroGenics gave an update on recent business developments and released financial results for the three months ended September 30, 2022. Through its partnering activities, MGNX said in an update that it has improved its financial condition. MGNX attained it by receiving $60 million upfront from Gilead for its newly announced MGD024 cooperation, as well as $30 million in milestone payments from Incyte throughout the quarter.
MacroGenics (MGNX) is also committed to developing its preclinical and clinical product candidates pipeline. The MGD024 dose-escalation trial and the MGC018 combination study with lorigerlimab will continue to recruit participants, and MGNX is expected to start the MGC018 TAMARACK study later this year. Data from the lorigerlimab monotherapy expansion cohorts will be reported in early 2023.