BioVie Inc. announced the results of a Type B meeting request submitted to the Food & Drug Administration (“FDA”) regarding its planned Phase 3 study of BIV201 (continuous infusion terlipressin) in hepatorenal syndrome–acute kidney injury (“HRS-AKI”). HRS-AKI is a life-threatening condition that may occur in patients with ascites due to advanced liver cirrhosis and has a mortality rate of approximately 50% over 2-4 weeks if left untreated. Based on communications with the FDA, the Company believes that positive results from a single pivotal Phase 3 clinical trial could potentially support the filing of a New Drug Application (NDA) and eventual approval of BIV201 for the treatment of HRS-AKI. BioVie recently commenced a Phase 2b clinical study of BIV201 in ascites due to liver cirrhosis. Pursuing the development of BIV201 for HRS-AKI represents a strong strategic fit with the ascites program. Given the overlap of these serious complications in cirrhotic patients, clinical team and expert medical advisors possess an in-depth understanding of HRS-AKI and the study can be conducted by the same clinical investigators at the same study centers as ascites trial.