BioVie (NASDAQ:BIVI) is a clinical-stage biopharmaceutical company focused on the development of novel small molecule therapies for neurological and gastrointestinal disorders. The company’s lead investigational product, NE3107, is an oral anti-inflammatory and insulin-sensitizing agent being evaluated for the treatment of mild-to-moderate Alzheimer’s disease. In addition to its Alzheimer’s program, BioVie is advancing NE3107 in Phase II studies for diabetic and idiopathic gastroparesis, nonalcoholic steatohepatitis (NASH)-related cirrhosis with portal hypertension, and primary biliary cholangitis (PBC). These programs seek to address significant unmet medical needs by targeting common pathways of inflammation and metabolic dysfunction.
Founded in 2015 and headquartered in Alameda, California, the company has built a pipeline aimed at leveraging NE3107’s mechanism of action across multiple indications. BioVie has entered into strategic collaborations and licensing agreements to support its global clinical development. Notably, the company secured rights to conduct Phase II/III trials of NE3107 in the People’s Republic of China, expanding its geographic footprint and fostering research partnerships in Asia.
Research and development efforts are supported by a network of academic and clinical research institutions in North America and abroad. BioVie’s scientific advisory board includes experts in neurodegenerative and gastrointestinal diseases, guiding trial design and regulatory strategy. The company’s manufacturing and formulation capabilities enable scalable production of its oral drug candidates under current Good Manufacturing Practice (cGMP) standards.
BioVie is led by an executive team with decades of combined experience in drug development, regulatory affairs and biopharmaceutical finance. Its management and board of directors draw upon deep expertise in clinical trial operations, corporate strategy and commercial planning. With a targeted pipeline and a focus on chronic, progressive diseases, BioVie aims to bring new therapeutic options to patients with limited treatment alternatives.
