BioVie is a clinical-stage biopharmaceutical company developing drug candidates for neurodegenerative conditions and liver cirrhosis complications. BioVie has no approved products and generates no revenue from product sales. The company’s lead candidate, bezisterim, is an oral small molecule designed to inhibit neuroinflammation and insulin resistance. BioVie is evaluating bezisterim for Parkinson’s disease, Alzheimer’s disease, and neurocognitive symptoms of long COVID. A Phase 2b trial in Parkinson's disease recently met its primary endpoint for reducing neuroinflammation, and BioVie is planning a Phase 3 trial. A Phase 2 trial for long COVID is also ongoing. BioVie's second candidate, BIV201, is a proprietary liquid formulation of terlipressin delivered via continuous infusion for ascites, a complication of advanced liver cirrhosis. The FDA has not approved any drug specifically for ascites, and BioVie’s formulation is room-temperature stable and delivered through a prefilled syringe to improve outpatient convenience. BioVie is finalizing Phase 3 trial designs for BIV201. The company's business model relies on external funding through equity raises and government grants to advance its clinical pipeline. BioVie operates with a lean staff of 13 employees and depends on outside consultants for scientific and regulatory work. The company's value is entirely contingent on clinical and regulatory outcomes.
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