NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

RADNOR, Pa., Jan. 16, 2024 /PRNewswire/ — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis.  Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101’s already strong 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. In addition to the marketplace protections conferred by QIDP designation in the US, NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. The data that formed the basis of FDA’s QIDP approval have been submitted for publication. On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women’s health for commercialization of NRX-101.

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