By Chris WackAridis Pharmaceuticals said Wednesday that the U.S. Food and Drug Administration has granted Qualified Infectious Disease Product Designation for AR-301, a fully human IgG1 monoclonal antibody in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus. The company received positive feedback from the FDA in May on its proposed single confirmatory Phase 3 study of AR-301. The company said an estimated 1 million patients annually are affected by ventilator associated pneumonia, which occurs in hospitalized patients receiving respiratory support. Aridis shares were up 64% to 44 cents in premarket trading. Write to Chris Wack at chris.wack@wsj.com(END) Dow Jones Newswires07-12-23 0835ET

Source: Wall Street Journal July 12, 2023 20:03 UTC