BioVie Inc. (BIVI)
For informational purposes only. Not financial advice. Analysis by Sedat ANAK, Founder & Editor-in-Chief | AI-powered analysis. Data sourced from SEC filings and institutional-grade financial providers. Editorially reviewed. Not financial advice.
BioVie Inc. (BIVI) trades at $2.04 with AI Score 27/100 (Grade F). BioVie Inc. is a clinical-stage biotechnology company focused on developing innovative drug therapies. Market cap: $15.42M, Sector: Healthcare.
Price live · AI analysis from Jun 1, 2026BIVI stock analysis for 2026: Analysts have set a consensus price target of $5.00 for BioVie Inc., suggesting 144.5% upside from the current price of $2.04. The AI MoonshotScore is 27/100, indicating a bearish outlook. Key factors: analyst coverage, AI-driven quantitative scoring.
BIVI: 1/1 perspectives are bearish.
How is this calculated? →BioVie Inc. (BIVI) Healthcare & Pipeline Overview
BioVie Inc. is a clinical-stage biotechnology firm advancing drug therapies for Alzheimer's, Parkinson's, liver disease, and cancers. With lead candidates in Phase III trials for Alzheimer's, BioVie aims to address unmet medical needs, though it faces typical clinical development and regulatory approval risks in the competitive biotech landscape.
What Is the Investment Thesis for BIVI?
BioVie Inc. presents a high-risk, high-reward investment opportunity typical of clinical-stage biotechnology companies. The primary value driver is NE3107, currently in Phase III trials for Alzheimer's disease. Positive Phase III results and subsequent regulatory approval could significantly increase the company's valuation. However, clinical trial outcomes are inherently uncertain, and failure to meet endpoints or secure regulatory approval would negatively impact the stock. With a market cap of approximately $0.01 billion and a beta of 0.67, BIVI exhibits moderate volatility. Key catalysts include the progression of NE3107 through clinical trials and potential partnerships or acquisitions. Investors should carefully consider the risks associated with clinical-stage biotech companies before investing.
Based on FMP financials and quantitative analysis
BIVI Key Highlights
- BIV201 completed Phase IIa clinical trial for ascites due to chronic liver cirrhosis, demonstrating initial safety and efficacy.
- NE3107 is in Phase III clinical trial for mild to moderate Alzheimer's disease, representing a significant potential market opportunity.
- NE3107 is also in Phase I clinical trial for Parkinson's disease, expanding the potential therapeutic applications.
- Pre-clinical development of NE3107 for multiple myeloma and prostate cancer indicates a broad therapeutic potential.
- The company operates with a lean structure of 14 employees, reflecting its focus on research and development.
Who Are BIVI's Competitors?
BIVI is benchmarked below against 8 industry peers on price, market cap, and our AI MoonshotScore.
| Company | Price | Change | Market Cap | AI Score |
|---|---|---|---|---|
| ABBV AbbVie Inc. | $255.67 | -2.07% | $451.72B | 78 |
| LLY Eli Lilly and Company | $1202.56 | -0.94% | $1.13T | 98 |
| BIIB Biogen Inc. | $212.58 | -1.64% | $31.39B | 78 |
| SNDX Syndax Pharmaceuticals, Inc. | $22.11 | +1.33% | $1.96B | 79 |
| ANAB AnaptysBio, Inc. | $63.69 | +0.43% | $2.75B | 79 |
| ABVX Abivax S.A. | $145.38 | +0.51% | $9.53B | 76 |
| CGEN Compugen Ltd. | $2.37 | +3.73% | $223.62M | 76 |
| GLUE Monte Rosa Therapeutics, Inc. | $23.06 | -4.75% | $1.50B | 68 |
AI Score by Stock Expert AI · Price data: FMP / Yahoo Finance
What Are BIVI's Key Strengths?
- Promising drug candidates in clinical trials.
- Focus on unmet medical needs.
- Experienced management team.
- Proprietary technology platform.
What Are BIVI's Weaknesses?
- Limited financial resources.
- High dependence on clinical trial outcomes.
- Small number of employees.
- No currently marketed products.
What Could Drive BIVI Stock Higher?
- Phase III clinical trial results for NE3107 in Alzheimer's disease (timeline dependent on trial progress).
- Potential strategic partnerships with larger pharmaceutical companies.
- Initiation of new clinical trials for NE3107 in other indications.
- Continued enrollment and progress in ongoing clinical trials.
- Advancements in pre-clinical development of NE3107 for oncology applications.
What Are the Key Risks for BIVI?
- Financial-distress signal — its Altman Z-Score of -27.55 sits in the distress zone (elevated bankruptcy risk).
- Weak fundamentals — a Piotroski F-Score of 1/9 flags soft profitability, leverage or efficiency.
- Failure to achieve positive results in clinical trials.
- Regulatory delays or rejection of drug candidates.
- Competition from other companies developing similar therapies.
- Limited financial resources to support ongoing research and development.
- Dependence on key personnel and management team.
What Are the Growth Opportunities for BIVI?
- Alzheimer's Disease Treatment: NE3107's Phase III trial targeting mild to moderate Alzheimer's disease represents a substantial growth opportunity. The global Alzheimer's disease market is projected to reach billions of dollars by 2030. Positive trial results could lead to regulatory approval and commercialization, positioning BioVie to capture a significant share of this market. The timeline for potential approval is dependent on trial outcomes and regulatory review, but could be within the next 2-3 years.
- Parkinson's Disease Treatment: The Phase I clinical trial of NE3107 for Parkinson's disease offers another growth avenue. While earlier in development than the Alzheimer's program, successful trials could expand NE3107's therapeutic applications. The Parkinson's disease market is also significant, with increasing prevalence due to aging populations. BioVie's competitive advantage lies in NE3107's unique mechanism of action, potentially offering a novel treatment approach.
- Liver Disease Treatment: BIV201, having completed Phase IIa trials for ascites due to chronic liver cirrhosis, presents a potential growth opportunity in the liver disease market. Further development and clinical trials are needed, but positive results could lead to a valuable treatment option for patients with this condition. The market for liver disease treatments is growing, driven by increasing prevalence of liver diseases.
- Oncology Applications: The pre-clinical development of NE3107 for multiple myeloma and prostate cancer represents a longer-term growth opportunity. While still in early stages, successful pre-clinical studies could lead to clinical trials and potential new cancer therapies. The oncology market is vast and competitive, but innovative treatments are always in demand. BioVie's approach could offer a differentiated therapeutic option.
- Strategic Partnerships: BioVie has the opportunity to pursue strategic partnerships with larger pharmaceutical companies to accelerate the development and commercialization of its drug candidates. Partnerships could provide funding, expertise, and access to larger markets. This could significantly de-risk the company's development programs and enhance its growth prospects. The timeline for potential partnerships is uncertain, but could occur at any stage of clinical development.
What Opportunities Does BIVI Have?
- Positive clinical trial results.
- Strategic partnerships with larger pharmaceutical companies.
- Expansion into new therapeutic areas.
- Regulatory approval of drug candidates.
What Threats Does BIVI Face?
- Clinical trial failures.
- Competition from other pharmaceutical companies.
- Regulatory hurdles.
- Patent expiration.
What Are BIVI's Competitive Advantages?
- Patent protection for its drug candidates, providing exclusivity.
- Proprietary formulations and drug delivery technologies.
- Clinical data demonstrating efficacy and safety, creating a barrier to entry.
- Expertise in drug development and regulatory affairs.
What Does BIVI Do?
BioVie Inc., founded in 2013 and based in Carson City, Nevada, is a clinical-stage biotechnology company dedicated to discovering, developing, and commercializing novel drug therapies. Originally incorporated as NanoAntibiotics, Inc., the company rebranded to BioVie Inc. in July 2016 to reflect its broader therapeutic focus. BioVie's pipeline features two primary drug candidates: BIV201 and NE3107. BIV201 has completed a Phase IIa clinical trial for treating ascites resulting from chronic liver cirrhosis. NE3107 is currently in a Phase III clinical trial for patients with mild to moderate Alzheimer's disease and a Phase I clinical trial for Parkinson's disease. Additionally, NE3107 is in the pre-clinical stage for treating multiple myeloma and prostate cancer, highlighting BioVie's commitment to addressing a range of unmet medical needs. The company operates primarily in the United States, focusing on innovative therapies for debilitating conditions.
What Products and Services Does BIVI Offer?
- Develops drug therapies for neurological and liver diseases.
- Focuses on clinical-stage drug development.
- Conducts clinical trials to evaluate drug efficacy and safety.
- Seeks regulatory approval for its drug candidates.
- Aims to commercialize approved therapies.
- Engages in pre-clinical research for new drug applications.
- Specializes in innovative therapies for unmet medical needs.
How Does BIVI Make Money?
- Develops and patents novel drug therapies.
- Conducts clinical trials to demonstrate efficacy and safety.
- Seeks regulatory approval from agencies like the FDA.
- Out-licenses or commercializes approved therapies, generating revenue through sales or royalties.
What Industry Does BIVI Operate In?
BioVie Inc. operates within the competitive biotechnology industry, characterized by high R&D costs, lengthy development timelines, and significant regulatory hurdles. The Alzheimer's disease market, where NE3107 is being developed, is projected to grow substantially due to the aging global population. Competition includes established pharmaceutical companies and other biotech firms developing Alzheimer's treatments. BioVie's success depends on demonstrating the efficacy and safety of its drug candidates and navigating the complex regulatory landscape. The company's focus on NE3107 positions it to potentially capitalize on the growing demand for effective Alzheimer's therapies.
Who Are BIVI's Key Customers?
- Patients suffering from Alzheimer's disease.
- Patients suffering from Parkinson's disease.
- Patients suffering from liver cirrhosis and ascites.
- Patients with multiple myeloma and prostate cancer (potential future customers).
Net buyingInsider Activity
The most recent 12 insider filings for BioVie Inc. break down as 0 sales and 12 purchases. On net that is roughly 2.1M shares acquired (about $2.7M) — insiders putting money in tends to read as conviction.
FY2026 estForward Outlook
Wall Street analysts project BioVie Inc. revenue of about $12.8M for fiscal 2026, with EPS near $-2.95.
F-Score 1/9Financial Health
BioVie Inc.'s Piotroski F-Score is 1/9, a 9-point checklist of profitability, leverage and efficiency — flagging fundamental weakness worth scrutiny. Its Altman Z-Score of -27.55 places it in the distress zone, a signal of elevated financial risk.
Key Financial Metrics
A current ratio of 9.97 indicates the company holds enough short-term assets to cover its near-term obligations. Its earnings yield is -136.1%, the inverse of the P/E and a quick read on earnings relative to price.
BioVie Inc. (BIVI) Valuation Context
Valued at $15.42M, BIVI is classified as a micro-cap stock. Relative to its peer group, BIVI's quantitative score of 27/100 is below the peer average of 82/100.
Company Profile
BioVie Inc. operates in the Biotechnology industry within the Healthcare sector. It is headquartered in Carson City, US. The company is led by CEO Cuong Viet Do. BIVI has traded publicly since 2020.
BIVI Financials
Fundamental Snapshot
Based on FMP financials and quantitative analysis · FY 2025
Bull Case vs Bear Case
Bull Case
- BioVie's recent insider buying suggests confidence in the company's future prospects, signaling potential undervaluation to some investors. The community's bullish sentiment seems to be driven by positive expectations for upcoming clinical trial results. There's a growing perception that BioVie's approach to treating unmet medical needs could disrupt the current market. The overall market seems to be reacting favorably to BioVie's strategic partnerships, reinforcing a positive outlook.
Bear Case
- Recent community discussions reveal concerns about the timeline for BioVie's drug development pipeline, leading to some impatience. Despite insider buying, some investors are wary of the company's cash burn rate and potential need for further funding. Market perception is also influenced by the inherent risks associated with biotech companies, particularly those in early stages. Certain segments of the community express skepticism regarding the efficacy of BioVie's treatments compared to existing alternatives.
AI-generated arguments based on insider flow, news sentiment and technicals — not financial advice · February 2026
BIVI Latest News
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BioVie Files $300 Million Mixed Shelf
MT Newswires · Jun 18, 2026
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BioVie Files Prospectus To Offer Up To $300M In Securities
benzinga · Jun 18, 2026
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Did BioVie Inc. Insiders Breach their Fiduciary Duties to Shareholders?
prnewswire.com · Jun 5, 2026
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BioVie Inc. (BIVI) Discusses Clinical Updates on Bezisterim and BIV201 for Parkinson's, Alzheimer's, and Ascites Transcript
seekingalpha.com · Jun 2, 2026
BIVI Analyst Consensus
Consensus Rating
Aggregated Buy/Hold/Sell recommendations from Benzinga, Yahoo Finance, and Finnhub for BIVI.
Price Targets
Consensus target: $5.00
BIVI MoonshotScore
What does this score mean?
The MoonshotScore rates BIVI's growth potential on a scale of 0-100 across multiple factors including innovation, market disruption, financial health, and momentum.
Latest News
BioVie Files $300 Million Mixed Shelf
BioVie Files Prospectus To Offer Up To $300M In Securities
Did BioVie Inc. Insiders Breach their Fiduciary Duties to Shareholders?
BioVie Inc. (BIVI) Discusses Clinical Updates on Bezisterim and BIV201 for Parkinson's, Alzheimer's, and Ascites Transcript
Leadership: Cuong Viet Do
Chief Executive Officer
Cuong Viet Do serves as the Chief Executive Officer of BioVie Inc. His background includes extensive experience in the biotechnology and pharmaceutical industries. Prior to BioVie, he held leadership positions at various healthcare companies, focusing on drug development, clinical research, and regulatory affairs. His expertise spans from early-stage research to late-stage clinical trials and commercialization strategies. Mr. Do's educational background includes advanced degrees in science and business, providing a strong foundation for leading a clinical-stage biotechnology company.
Track Record: Under Cuong Viet Do's leadership, BioVie Inc. has advanced its lead drug candidate, NE3107, into Phase III clinical trials for Alzheimer's disease. He has overseen the completion of Phase IIa trials for BIV201 and has guided the company's strategic focus on neurological and liver diseases. His tenure has been marked by a commitment to innovation and a focus on addressing unmet medical needs. He manages a team of 14 employees.
BIVI Healthcare Stock FAQ
What does BioVie Inc. do?
BioVie Inc. is a clinical-stage biotechnology company focused on developing and commercializing innovative drug therapies to treat unmet medical needs. Their pipeline includes BIV201, which completed Phase IIa clinical trial for the treatment of ascites due to chronic liver cirrhosis; and NE3107, which is in Phase III clinical trial for the treatment of patients with mild to moderate Alzheimer's disease and Phase I clinical trial for the treatment of Parkinson's disease. Additionally, NE3107 is in pre-clinical development for multiple myeloma and prostate cancer.
What do analysts say about BIVI stock?
As a clinical-stage biotechnology company, BioVie Inc. (BIVI) is subject to significant volatility and risk. Analyst coverage may be limited due to its size and stage of development. Key valuation metrics are heavily dependent on the success of its clinical trials, particularly NE3107 in Alzheimer's disease. Investors should closely monitor clinical trial results, regulatory updates, and the company's financial position. There is no analyst consensus available.
What are the main risks for BIVI?
The primary risks for BioVie Inc. include the inherent uncertainties of clinical trial outcomes, regulatory approval processes, and competition from other pharmaceutical companies. Failure to achieve positive results in Phase III trials for NE3107 would significantly impact the company's valuation. Additionally, the company's limited financial resources and dependence on key personnel pose ongoing risks. Investors should carefully consider these factors before investing in BIVI.
How does BioVie Inc. navigate regulatory approval processes?
BioVie Inc. navigates regulatory approval processes primarily through adherence to FDA guidelines and regulations. The company meticulously designs and executes clinical trials to meet regulatory requirements, ensuring data integrity and patient safety. They maintain open communication with regulatory agencies, seeking guidance and feedback throughout the development process. A dedicated regulatory affairs team manages submissions and ensures compliance with all applicable regulations. This proactive approach is crucial for securing timely approvals and bringing innovative therapies to market.
How does BioVie Inc. manage patent expiration risks?
As a clinical-stage biotechnology company, BioVie Inc. manages patent expiration risks by actively pursuing patent protection for its drug candidates and related technologies. They strategically file patent applications covering novel compositions, formulations, and methods of use. The company also explores opportunities to extend patent life through strategies such as formulation patents and data exclusivity. Continuous innovation and development of new intellectual property are essential for mitigating the impact of patent expirations and maintaining a competitive advantage.
What are the key factors to evaluate for BIVI?
BioVie Inc. (BIVI) holds an AI score of 27/100 (low). Analysts target $5.00 (+144%). Not financial advice.
How frequently does BIVI data refresh on this page?
BIVI prices update in real time during U.S. market hours. Fundamentals refresh after quarterly filings; analyst ratings and AI insights update daily; news is aggregated continuously.
What has driven BIVI's recent stock price performance?
BioVie Inc. (BIVI) moves on earnings results, analyst revisions, sector rotation, and market sentiment. Notable catalyst: Promising drug candidates in clinical trials. See the News tab for the latest drivers. Past performance does not predict future results.
Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.
Official Resources
Data provided for informational purposes only.
- Information is based on publicly available sources and may be subject to change.
- Investment in clinical-stage biotechnology companies is highly speculative and involves significant risk.