Biovie Stock Price, News & Analysis
Company Description
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing drug therapies for neurological and neurodegenerative disorders and advanced liver disease. According to the company’s public disclosures, BioVie is advancing product candidates that target underlying biological drivers such as neuroinflammation, insulin resistance, and complications of advanced liver cirrhosis.
Core therapeutic focus
BioVie states that it is developing treatments for Alzheimer’s disease, Parkinson’s disease, long COVID, and advanced liver disease. In its neurology programs, the company’s lead candidate is bezisterim (NE3107), described as an orally bioavailable, blood-brain barrier–permeable modulator of inflammation and an insulin-sensitizing agent. Company materials explain that bezisterim is being studied in Alzheimer’s disease, Parkinson’s disease, and long COVID, where persistent inflammation and insulin resistance are believed to contribute to neurological damage and cognitive or motor symptoms.
In liver disease, BioVie reports that it is advancing BIV201, a continuous infusion formulation of terlipressin for patients with complications of advanced liver cirrhosis, including refractory ascites. The company notes that BIV201 has received FDA Orphan Drug designation and Fast Track status, and that the active agent is approved in the United States and in about 40 countries for related complications of advanced liver cirrhosis. BioVie has indicated that it is working with the U.S. Food and Drug Administration on the design of a Phase 3 clinical program to evaluate BIV201 for the reduction of further decompensation in participants with cirrhosis and ascites.
Bezisterim (NE3107) mechanism and indications
BioVie describes bezisterim as a small molecule that binds to ERK and selectively modulates NFκB activation and TNF-α production, aiming to reduce inflammatory activation while preserving ERK and NFκB homeostatic functions such as insulin signaling and neuron growth and survival. Company communications state that both neuroinflammation and insulin resistance are considered drivers of Alzheimer’s disease and Parkinson’s disease, and that persistent systemic inflammation and neuroinflammation are key features in patients with neurological symptoms of long COVID.
In Parkinson’s disease (PD), BioVie has reported completion of a Phase 2 study in patients with moderate-to-severe PD taking bezisterim in combination with levodopa/carbidopa. Data presented by the company indicated improvements in “morning on” symptoms and clinically meaningful improvements in motor control compared with levodopa alone, with no drug-related adverse events reported in that study. The company is now conducting the SUNRISE-PD Phase 2 trial in individuals with early-stage PD who have not been treated with carbidopa/levodopa. SUNRISE-PD is described as a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design, allowing study visits either at home or in a clinic, supported by in-home nurse visits, remote neurologist oversight, and centralized motor assessments.
In Alzheimer’s disease (AD), BioVie has conducted a Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study of bezisterim in patients with mild-to-moderate Alzheimer’s disease. The company has also referenced a Phase 2 investigator-initiated trial in which bezisterim-treated patients experienced improved cognition and biomarker levels, with data presented at the Clinical Trials on Alzheimer’s Disease conference. In separate analyses of the Phase 3 study, BioVie has highlighted that bezisterim treatment appeared to be associated with changes in DNA methylation patterns across multiple biological clocks and genes related to inflammation, metabolism, aging, and Alzheimer’s disease pathophysiology, as well as changes in metabolic and inflammatory biomarkers.
For long COVID, BioVie is sponsoring the ADDRESS-LC Phase 2 trial, a multicenter, double-blind, randomized, placebo-controlled study evaluating bezisterim in adults with long COVID who are enriched for fatigue and cognitive impairment. The company notes that the study is fully funded by a grant from the U.S. Department of Defense and is designed with input from clinicians and patients, using enrichment and stratification strategies (such as symptom duration and age groups) and objective cognitive endpoints to assess potential effects on brain fog and fatigue.
Liver disease program: BIV201
In its liver disease franchise, BioVie is developing BIV201, described as a continuous infusion terlipressin therapy intended for patients with advanced liver cirrhosis and complications such as refractory ascites. Company disclosures state that BIV201 has Orphan Drug designation and Fast Track status from the FDA. BioVie indicates that it has been in discussions with the FDA regarding Phase 3 clinical testing of BIV201 to evaluate whether treatment can reduce further decompensation events in patients with cirrhosis and ascites. The active agent in BIV201 is reported to be approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.
Clinical development approach
Across its neurology programs, BioVie emphasizes patient-centric and accessible trial designs. For example, the SUNRISE-PD trial uses a hybrid, decentralized model that allows participants to complete visits at home or in a clinic, with digital tools, virtual documentation, and centralized rating committees for motor assessments. The ADDRESS-LC trial incorporates enrichment strategies and stratification by symptom duration and age to enhance signal detection and relevance to the long COVID population. Company presentations highlight the use of objective cognitive testing platforms and biomarker analyses to better understand disease mechanisms and potential treatment effects.
BioVie’s public statements describe bezisterim as not immunosuppressive and having a low risk of drug–drug interactions, with favorable safety and tolerability profiles observed across clinical trials in Alzheimer’s disease and Parkinson’s disease. The compound is characterized as orally bioavailable and able to cross the blood–brain barrier, with proposed effects on inflammatory signaling cascades and metabolic pathways that may be relevant to neurodegeneration and systemic inflammation.
Corporate and capital markets information
BioVie Inc. is incorporated in Nevada and lists its Class A common stock on The Nasdaq Stock Market under the symbol BIVI. The company has also listed warrants to purchase Class A common stock on Nasdaq under the symbol BIVIW, following an underwritten public offering of units consisting of common stock (or pre-funded warrants) and warrants. In connection with that offering, BioVie filed a registration statement on Form S-1 and subsequent amendments, and entered into an underwriting agreement and a warrant agent agreement, as described in its Form 8-K filings.
BioVie has also reported corporate governance and equity compensation matters through SEC filings, including amendments to its 2019 Omnibus Equity Incentive Plan to increase the number of shares authorized for issuance, and the election and appointment of directors at its annual meeting of stockholders. The company has implemented a reverse stock split of its common stock at a ratio of one-for-ten, effective July 7, 2025, as disclosed in a Form 8-K, with trading on Nasdaq continuing on a split-adjusted basis.
Regulatory filings and reporting
As a Nasdaq-listed issuer, BioVie files reports with the U.S. Securities and Exchange Commission, including Forms 10-K, 10-Q, 8-K, proxy statements on Schedule 14A, and registration statements such as Form S-1. These filings provide additional detail on the company’s clinical programs, risk factors, capital structure, governance, and financial condition. Investors researching BIVI stock can review these documents for a more complete picture of the company’s operations and development plans.
Summary of key programs
- Bezisterim (NE3107): Oral, blood–brain barrier–permeable modulator of inflammation and insulin sensitizer, studied in Alzheimer’s disease, Parkinson’s disease, and long COVID.
- SUNRISE-PD: Phase 2, multicenter, randomized, double-blind, placebo-controlled, hybrid decentralized trial in early Parkinson’s disease patients not yet treated with carbidopa/levodopa.
- ADDRESS-LC: Phase 2, multicenter, randomized, double-blind, placebo-controlled trial in adults with long COVID–related fatigue and cognitive impairment, fully funded by a U.S. Department of Defense grant.
- Alzheimer’s disease studies: Phase 3 and Phase 2 trials evaluating bezisterim in mild-to-moderate Alzheimer’s disease, with reported signals in cognition, biomarkers, and epigenetic measures of biological aging.
- BIV201: Continuous infusion terlipressin program for advanced liver cirrhosis and ascites, with FDA Orphan Drug and Fast Track designations and planned Phase 3 evaluation for reduction of further decompensation.
According to its public descriptions, BioVie’s overall strategy centers on targeting inflammatory and metabolic pathways that may underlie multiple chronic, debilitating conditions in neurology and hepatology, using clinical trials and regulatory interactions to evaluate the potential of its drug candidates.