bivi stock: BioVie Inc. Guide

BioVie Inc. (BIVI)

bivi stock refers to BioVie Inc., a clinical‑stage biopharmaceutical company listed on the NASDAQ under the ticker symbol BIVI. This article explains what bivi stock represents, the company's core business and pipeline, clinical programs and regulatory status, plus high‑level market and shareholder information relevant to investors and researchers.

As of Jan 25, 2026, according to company investor materials and major market quote pages, BioVie is classified as a micro‑cap biotech with development‑stage finances and volatility typical of clinical‑stage drug developers. This guide is intended to be informational and neutral; it does not provide investment advice.

Corporate overview

BioVie Inc. (BIVI) is incorporated in the United States and headquartered in Carson City, Nevada. The company describes its mission as developing therapeutics for neurological and liver disease indications with unmet medical need. BioVie operates as a clinical‑stage biopharmaceutical company focused on advancing multiple clinical programs rather than generating product revenue at this stage.

BioVie’s workforce size and corporate structure are consistent with a research‑driven small biotech: a compact executive team supported by program‑specific research, clinical and regulatory staff, and outsourced partners for manufacturing and CRO (clinical research organization) services.

History

BioVie’s corporate timeline includes incorporation and name evolution, public listing events and capital raises typical of small biotech sponsors. Historically, the company has advanced candidates into human studies while conducting financings to support clinical development.

Key historical points reported in company filings and market coverage include initial public listing on NASDAQ under the ticker BIVI, subsequent registered offerings to raise development capital, and announcements of Phase II/III trial starts or milestone achievements. As with many clinical‑stage firms, these corporate milestones have influenced the trading pattern of bivi stock.

As of Jan 25, 2026, according to BioVie investor releases, the company has completed multiple financings to support its lead programs and appointed board and management members with clinical and commercial experience to its governance team.

Business operations and strategy

BioVie’s operating model centers on internal program leadership combined with external partnerships for specialized functions. The company focuses on advancing clinical programs through pivotal trials or asset‑level partnerships/licensing when appropriate.

The stated strategy includes progressing lead candidates to registrational trials where supported by data, exploring licensing or collaboration opportunities to accelerate development or commercialization, and preserving balance sheet runway through capital markets access.

Research and development approach

BioVie’s R&D approach emphasizes repurposing or advancing molecules with biological rationales for neuroinflammation, neurodegeneration and liver disease. The company’s candidate programs use mechanisms such as modulation of inflammatory signaling pathways (including TNF‑α related approaches cited in investor materials) and vasoactive peptides for liver disease management.

Clinical focus is placed on well‑defined patient populations with measurable endpoints, and the company uses standard randomized controlled trial designs where feasible. BioVie relies on CRO partnerships, academic collaborators and commercially relevant diagnostic endpoints to generate data that could support regulatory filings.

Product pipeline and lead candidates

Below are the principal pipeline candidates publicly referenced by BioVie and market coverage. Each entry is a concise program description drawn from company materials and clinical trial registries.

• NE3107 (NE‑3107): A small molecule evaluated for neuroinflammatory and neurodegenerative indications, including evaluation in Alzheimer’s disease. Company disclosures indicate progression to Phase III development for a targeted indication per press releases and clinical registry entries.

• Bezisterim (candidate names vary in company materials): A therapeutic with a mechanism addressing TNF‑α related pathways, pursued for Parkinson’s disease and neurological symptoms associated with long COVID. BioVie materials reference TNF‑α inhibition or modulation as part of the therapeutic rationale and trial designs.

• BIV201 (continuous infusion terlipressin): A formulation focused on liver disease indications such as ascites due to chronic liver cirrhosis; BioVie has explored Phase II/III development concepts for terlipressin administration approaches.

• Other preclinical or early clinical programs: Company reports reference additional exploratory assets or earlier‑stage research that support the broader pipeline; these assets are typically advanced to IND‑enabling work or partnered development when appropriate.

Clinical trials and key studies

BioVie lists multiple trials across its pipeline. Major trials referenced in public filings and trial registries include a Phase III program for NE3107, and disease‑specific studies such as trials identified by names like ADDRESS‑LC and SUNRISE‑PD in company materials.

Typical objectives for these trials are to assess efficacy on clinical endpoints relevant to the indication (e.g., cognitive scales in Alzheimer’s disease, motor scales in Parkinson’s disease, ascites control in liver disease), safety and tolerability, and biomarker readouts where applicable.

As of Jan 25, 2026, according to BioVie press releases and trial registries, the company had reported enrollment updates and expected timing for interim or full data readouts for select trials. These milestones have historically driven short‑term volatility in bivi stock as investors respond to clinical progress or delays.

Regulatory status

BioVie’s regulatory interactions primarily involve standard clinical trial filings and communications with regulators for trial design and potential registration pathways. The company has described trial designs intended to support regulatory submissions should pivotal data meet predefined endpoints.

No marketing approvals for any BioVie product were reported as of Jan 25, 2026. Ongoing or planned pivotal trials would be necessary prerequisites for regulatory approval in major markets.

Financial information

bivi stock trades on the NASDAQ under the symbol BIVI. As a clinical‑stage company, BioVie historically reports limited or no product revenue and records R&D and SG&A expenses associated with clinical programs.

Cash position, debt levels and recent financing activity are disclosed in the company’s quarterly and annual SEC filings. Historically, BioVie has accessed public capital markets through registered offerings and may engage in additional financings, which can dilute existing shareholders and affect bivi stock.

As of Jan 25, 2026, company filings and market pages show that BioVie operates with development‑stage financials: negative earnings per share (EPS) and reliance on capital raises to fund trials. Readers should consult the latest Form 10‑Q or Form 10‑K filings for precise cash, debt and operating expense figures.

Stock market information

Key trading facts for bivi stock:

• Ticker and exchange: BIVI on the NASDAQ.

• Market classification: Micro‑cap biotech with trading volatility typical for small clinical‑stage companies.

• Liquidity and volume: Trading volume for bivi stock can vary widely around newsflow, clinical updates and capital market transactions. Market quote pages (e.g., Yahoo Finance, CNBC, Morningstar) provide real‑time volume and 52‑week range data.

• Price volatility: Clinical announcements, trial milestones, financings and analyst commentary tend to drive intraday and multi‑day movements in bivi stock.

As of Jan 25, 2026, according to market quote sources, bivi stock’s 52‑week price range and recent notable price moves are documented on major financial pages; consult those pages for up‑to‑date numerical values if you require exact figures.

Shareholders and ownership

Public filings and market analytics summarize insider and institutional ownership in BIVI. Typical ownership profiles for comparable micro‑cap biotechs include a mix of company insiders, venture or biotech‑specialist institutions, and retail investors.

Short interest and options activity may be reported on financial data platforms and in SEC filings; these metrics can affect liquidity and price dynamics for bivi stock when large positions are opened or closed.

Corporate governance and management

BioVie’s management team and board composition are detailed in company proxy statements and investor materials. Key executives typically include a Chief Executive Officer, Chief Medical Officer or Head of R&D, and a Chief Financial Officer. Board members often have backgrounds in life sciences, clinical development or capital markets.

Corporate governance disclosures and insider transactions are available in SEC filings and investor relations announcements; these items can inform assessments of alignment between management and shareholders.

Legal matters and litigation

Public reports and investor notices occasionally reference securities litigation or investor alerts involving micro‑cap biotech companies following material events. For BioVie, any publicly reported legal or regulatory actions would be disclosed in SEC filings and press releases.

As of Jan 25, 2026, according to court filings and legal notices aggregated by market news providers, there were no universally reported, company‑wide legal judgments that altered the company’s clinical development plan. Readers should check the company’s SEC filings and press releases for the latest disclosures regarding litigation or regulatory inquiries.

Analyst coverage and market commentary

Analyst coverage of bivi stock is often limited compared with larger pharmaceutical companies. Where available, sell‑side and independent analyst notes focus on clinical readouts, trial design, cash runway and potential partnering opportunities.

Market commentary in business press and financial data sites reflects event‑driven coverage: trial initiations, interim results, regulatory interactions and financing announcements typically attract the most coverage and impact sentiment around bivi stock.

Risks

Investors and stakeholders should be aware of principal risks associated with bivi stock and BioVie’s business model. These include:

• Clinical development risk: Candidate therapies may fail to demonstrate safety and efficacy in trials, leading to program termination and negative market reaction.

• Regulatory risk: Even positive trial results must satisfy regulatory standards to achieve approval, and regulators may require additional data or analyses.

• Financing and dilution risk: As a development‑stage company, BioVie may need to raise capital, which can dilute existing shareholders and affect bivi stock.

• Liquidity and volatility risk: Micro‑cap equities like bivi stock often experience large price swings and low liquidity relative to large‑cap stocks.

• Legal and operational risk: Litigation, manufacturing challenges, or partner disagreements can materially affect development timelines and financial resources.

This list is illustrative, not exhaustive. For detailed risk disclosures, readers should consult BioVie’s SEC filings.

Investor relations and public disclosures

BioVie maintains an investor relations function that publishes SEC filings, press releases, investor presentations and scheduled webcasts. These IR resources are the primary source for official updates on trial progress, financial results and corporate actions.

As of Jan 25, 2026, according to company announcements and IR materials, upcoming milestones and scheduled webcasts are listed on the company’s investor relations page and in filings with the SEC. Investors should rely on these primary documents for verified information about bivi stock.

See also

• Lists of Nasdaq‑listed biotechnology companies
• Clinical‑stage biopharmaceutical company profiles
• Comparable tickers and peers in neurodegenerative and liver disease therapeutic areas

References

As of Jan 25, 2026, the material in this guide draws from the following public sources and market quote pages:

• BioVie Inc. — Investor Relations materials and press releases (company filings and announcements)
• Yahoo Finance — BIVI quote and market data (finance.yahoo.com/quote/BIVI/)
• CNN Markets — BIVI stock data and coverage
• Robinhood — BIVI profile and trading overview
• Public.com — BIVI market listing information
• CNBC — BIVI quote and brief analysis
• Morningstar — BIVI stock quote and financial snapshot
• eToro — BIVI market overview
• Nasdaq — Company page and market‑activity summary for BIVI
• Finviz — BIVI profile and basic financial metrics

Readers should consult the primary sources above for the most recent numerical data and filings. Official SEC filings (Forms 10‑Q, 10‑K and 8‑K) are the authoritative records of financials, risk disclosures and corporate actions.

Additional notes on bivi stock and how to follow updates

• For trial updates and enrollment milestones, monitor BioVie’s press releases and clinical trial registries.

• For near‑real‑time market data (price, volume and 52‑week range) consult major market quote pages listed in References.

• For corporate filings and governance disclosures, review the company’s SEC filings and proxy statements.

• For trading or custody of digital assets and Web3 wallets, consider Bitget Wallet and Bitget products for digital asset activity; this guide does not imply BioVie shares trade on Bitget — bivi stock is a NASDAQ‑listed equity.

Practical tips for readers

• Verify current market metrics before making any transaction: prices and volumes change intraday.

• Place special emphasis on clinical milestone dates and SEC filings when assessing event risk for bivi stock.

• Use investor relations contacts to request clarification on disclosures when needed.

• Keep in mind that small‑cap biotech equities like bivi stock can experience sudden price moves around news events.

Further exploration: review the company’s latest investor presentation and recent SEC filings to confirm cash runway, upcoming milestones and program timelines.

Thank you for reading. To explore digital asset tools and Web3 wallet options, learn about Bitget Wallet and Bitget platform services designed for secure custody and trading of supported digital assets.