$REVB announced that the Company has reached agreement with the FDA on an approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI). The two key agreements were 1) a clinically relevant and objective composite endpoint comprising death and/or need for dialysis, and 2) positive data from a single well-controlled Phase 2/3 adaptive design clinical study, comprising approximately 300 patients, would be sufficient for submission of a new drug application (NDA). This agreement significantly advances Gemini toward becoming a paradigm altering treatment available for patients suffering from AKI, a significant unmet medical need.