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Aridis Pharmaceuticals Inc (NASDAQ:ARDS) shares are gaining after announcing positive European Medicines Agency feedback on its proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301.
AR-301 is being developed as an adjunctive therapy with standard-of-care (SOC) antibiotics for pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
Key agreements by the EMA were similar to those agreed by the FDA, which include:
AR-301-003 will be the second and final of two planned Phase 3 superiority studies evaluating the efficacy and safety of AR-301 for adjunctive therapy of pneumonia caused by S. aureus in critically ill hospitalized patients.
Approximately 200 clinical sites in 20+ countries are expected to participate in the study.
Price Action: ARDS shares are up 29.40% at $0.34 during the premarket session on the last check Tuesday.
Posted In: ARDS