BioVie
$1.78
+0.0200 (1.14%)
Developing Care for Unmet Medical Challenges
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Company Overview
BioVie is a clinical-stage biopharmaceutical company advancing a differentiated pipeline targeting high-impact neurodegenerative and liver diseases. Its lead asset, bezisterim (formerly NE3107), is a first-in-class, orally available small molecule that modulates TNFα-driven inflammation and insulin resistance, two critical drivers of Alzheimer’s, Parkinson’s, and other age-related disorders. Bezisterim has demonstrated signals of improved cognition, motor function, and reduced neuroinflammation across clinical studies, with multiple mid- and late-stage trials ongoing across Alzheimer’s, Parkinson’s, and Long COVID, including a fully enrolled Phase 2 SUNRISE-PD trial with topline data expected in 1H 2026.. Complementing this CNS franchise, BioVie’s BIV201 program (continuous infusion terlipressin) is in late-stage development as a potential first therapeutic for refractory ascites, a life-threatening complication of liver cirrhosis. With compelling clinical data, orphan and large-market opportunities, and a leadership team with deep biopharma expertise, BioVie is positioned to unlock transformative treatments at the intersection of longevity, neurodegeneration, and liver disease.
Value Proposition
BioVie represents a unique late-clinical-stage investment opportunity at the convergence of neurodegeneration, longevity science, and liver disease. The company’s lead asset, bezisterim (NE3107), is a first-in-class, orally bioavailable small molecule that addresses two fundamental drivers of aging and neurodegeneration: TNFα-mediated inflammation and insulin resistance. Across clinical studies, bezisterim has generated encouraging signals of improved cognition in Alzheimer’s, motor function in Parkinson’s, and reduced biological aging as measured by DNA methylation “clocks,” underscoring its potential as a platform therapy for multiple large and underserved patient populations.
The scale of the commercial opportunity is substantial: Alzheimer’s alone represents a $30 billion U.S. market, with additional upside in Parkinson’s ($3 billion) and Long COVID (17 million affected U.S. adults). Importantly, bezisterim’s favorable safety profile and oral administration provide clear advantages over high-cost, infusion-based antibody therapies, positioning it for differentiated market adoption.
Complementing its neurology franchise, BioVie’s BIV201 program targets refractory ascites, a complication of liver cirrhosis with 50% one-year mortality and no FDA-approved therapies. Phase 2b data demonstrated a 53% reduction in ascites volume versus standard of care (p<0.001), establishing proof-of-concept for a potentially first-in-class therapy in a $1.6 billion U.S. market.
With multiple near-term catalysts, including topline results expected in 1H 2026 from the fully enrolled Phase 2 SUNRISE-PD Parkinson’s trial, initiation of a new Phase 3 in Alzheimer’s, advancement of Long COVID studies, and a Phase 3 program for ascites, BioVie offers investors multiple shots on goal for value creation. Anchored by a seasoned management team with deep regulatory and commercialization expertise and operating at the intersection of massive unmet need and multi-billion-dollar markets, BioVie is positioned to deliver transformative shareholder value as it advances toward pivotal data and potential partnerships.
Commercial Potential in US Market
Investor Presentation
Investment Highlights
Lead program with multi-disease potential
- Bezisterim (NE3107), an oral first-in-class small molecule that modulates TNFα-driven inflammation and insulin resistance
- Demonstrated signals of clinical benefit across Alzheimer’s, Parkinson’s, and Long COVID, with potential to become a platform therapy for age-related diseases
- Favorable safety profile with no significant safety issues observed through Phase 2
- Phase 2 trial in early Parkinson’s fully enrolled; topline data expected in 1H 2026
Significant unmet medical needs in PD, AD, and Long COVID
- $30+ billion annual peak sales potential in PD for bezisterim
- $3+ billion annual peak sales potential in AD for bezisterim
- 17M adults in US suffer from Long COVID; est. 30K new patients daily
Among competitive molecules exploring neuroinflammation and AD, bezisterim is the only one that:
- Published randomized, double-blinded, placebo Phase 2 results potentially suggesting reduction in inflammation and insulin resistance in a major population and warranting further review in Phase 3.
- Potentially inhibits both overarching mechanisms of AD pathology – inflammation and insulin resistance
- Potentially inhibits proinflammatory pathways without impacting homeostasis
BIV201 is the only drug currently in development for refractory ascites, a condition with 50% mortality rate. It has the potential to become first therapy since there are no approved drugs in the US
- BIV201 is a novel formulation of terlipressin for continuous infusion; Orphan and Fast Track designations received
- Data from Europe/Asia supports development; no drug-related SAEs in trials
- Phase 2b data: 53% reduction in ascites volume vs. standard of care (p<0.001)
- S. commercial opportunity estimated at $1.6B annually, with no FDA-approved therapies to date
- $1.6 billion global peak annual sales potential
Experienced leadership with proven track record
- Management team with 30+ years average industry experience, spanning regulatory affairs, drug development, and commercialization.
- CEO Cuong Do: former Chief Strategy Officer at Merck and President of Samsung Global Strategy Group.
- Deep expertise across CNS, liver disease, and biotech financing, providing a strong foundation for execution
Articles
Why This Small-Cap Biotech Stock Could be Worth $6 According to a Wall Street Analyst
Mar. 24, 2026 12 min read
Shares currently trading at $1.32, as of March 24, 2026. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company developing treatments for neurodegenerative diseases and advanced liver disease...
Read MoreClinical Trial Pipeline Stages
| Drug Name | Stage |
|---|---|
| BIV201DetailsAscites | Phase 3 |
| NE3107DetailsAlzheimer's disease | Phase 3 |
| Bezisterim (NE3107)DetailsParkinson's disease | Phase 2b |
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BioVie (BIVI) is a client of RedChip Companies, Inc. BIVI agreed to pay RedChip Companies, Inc., a $7,500 monthly cash fee, beginning in March 2022, for 12 months of RedChip investor awareness services. The CEO of RedChip Companies owns 3,150 shares of BIVI. BIVI also agreed to pay RedChip a $50,000 fee for a national TV ad campaign aired weekdays from June 17 through July 1, 2024 and October 21 to October 25, 2024, and a $37,500 fee plus 45,000 shares of Rule 144 stock for a national TV ad campaign aired May 1 to May 14, 2025. RedChip intends to and will, if possible, sell all of its shares immediately upon removal of the restriction, and you may be buying as RedChip is selling.
Investor awareness services and programs are designed to help small-cap companies communicate their investment characteristics. RedChip investor awareness services include the preparation of a research profile(s), multimedia marketing, and other awareness services.