United Therapeutics Corporation (UTHR), Wednesday announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to the company's investigational miroliverELAP for treatment of acute liver failure.
Developed by Miromatrix Medical Inc., a subsidiary of United Therapeutics, miroliverELAP comprises of an external blood circuit and a single-use bioengineered liver sustained outside of the human body to provide temporary liver support to ALF patients.
Early this year, the company announced positive results from its phase 1 study of miroliverELAP. However, the full study findings will be published in the second half of 2026.
"Receiving this designation from the FDA highlights both the critical unmet need we are addressing and the promising potential of miroliverELAP as a novel therapeutic option," said Jeff Ross, Ph.D., President of Miromatrix.
In the pre-market hours, UTHR is trading at $573.96, up 1.46 percent on the Nasdaq.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.