By Chris Wack

NRx Pharmaceuticals has received qualified infectious disease product and fast-track designation from the U.S. Food and Drug Administration for NRX-101 in the treatment of complicated urinary tract infections and pyelonephritis.

Receipt of QIDP designation confers priority review, and five additional years of data-exclusivity to NRX-101's intellectual property position.

The FDA also granted NRX-101 fast-track designation for cUTI, which additionally allows for rolling submission of the company's New Drug Application.

NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 16, 2024 07:10 ET (12:10 GMT)

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