Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
BIVI Catalyst Timeline
Dated clinical, regulatory and corporate events for BioVie Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for BioVie Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How BIVI actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-15 | bezisterim (NE3107) | Phase 2 topline data readout | Phase 2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NE3107 Small moleculeCompletedNCT05227820 | Alzheimer Disease | Phase 3 | COMPLETED | 462 | Aug 20, 2022 |
Clinical Trial Results
Readouts, endpoints and source filings for every BIVI program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| bezisterim | Long COVID | Phase 2 | 2026-09-15 | 21 out of 22 endpoints showing favorable trendsRead More | BioVie Announces Topline Results from Phase 2 ADDRESS‑LC Trial Evaluating Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVIDRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Palumbo Joseph MOfficer (Chief Medical Officer) | Buy | 4,843 6,036 held | $2.16 | 08/28/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in BIVI
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Ikarian Capital, LLC | 0.2 % (-33.3 %) | 1.56 M | 457.35 K | 1.96% ( 8.79 K) |
BIVI Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How BIVI ranks across every disease it competes in
BIVI News
BioVie Announces Topline Results from Phase 2 ADDRESS‑LC Trial Evaluating Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID
BioVie announced positive topline results from its Phase 2 ADDRESS-LC trial evaluating bezisterim for Long COVID. The trial demonstrated significant benefits in patients with high baseline symptom burden, with 21 out of 22 endpoints showing favorable trends. Bezisterim's safety profile was comparable to placebo, and the findings suggest potential for further development in a Phase 3 trial.
Read more →BioVie to Host Conference Call to Discuss Topline Data from Phase 2 ADDRESS-LC Trial and the Potential of Bezisterim in Long Covid
BioVie Inc. will host a conference call on September 15, 2026, to discuss topline results from its Phase 2 ADDRESS-LC trial evaluating bezisterim for Long COVID. The trial aims to assess the drug's efficacy in reducing cognitive impairment and fatigue. Guest speakers include a trial investigator and a patient advocate, with a Q&A session to follow. The study is funded by a $13.13 million grant from the U.S. Department of War.
Read more →BioVie Announces Update to Parkinson’s Phase 3 Development Program
BioVie Inc. has announced the next steps in its Phase 3 development program for bezisterim, targeting Parkinson's disease. The trial will focus on both motor and non-motor symptoms, with MDS-UPDRS 1 Part III as the primary endpoint. Phase 2 data suggest significant benefits for patients with elevated inflammation. The company is seeking FDA feedback on the trial design.
Read more →BioVie Announces Completion of Treatment Phase of ADDRESS-LC Trial of Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID
BioVie Inc. has completed the treatment phase of its ADDRESS-LC Phase 2 trial, which evaluates bezisterim for neurological symptoms associated with Long COVID. The trial, funded by the U.S. Department of War, aims to assess the drug's efficacy in improving cognitive function and reducing fatigue. Topline results are expected by the end of September 2026.
Read more →BioVie Announces Topline Results of Phase 2 SUNRISE-PD Trial of Bezisterim in Early Parkinson’s Disease
BioVie announced positive topline results from its Phase 2 SUNRISE-PD trial for bezisterim in early Parkinson's disease. The trial demonstrated significant improvements in both motor and non-motor symptoms compared to placebo, alongside beneficial effects on biomarkers of neurodegeneration and inflammation. The results suggest bezisterim may provide a new therapeutic approach targeting the underlying biology of Parkinson's disease.
Read more →Join BioVie’s Exclusive Live Investor Webinar and Q and A Session on June 2
BioVie Inc. is hosting a live investor webinar on June 2, 2026, featuring CEO Cuong Do. The presentation will cover bezisterim, an investigational drug for neuroinflammation, and BIV201, a late-stage candidate for liver disease. The event will include a Q&A session, highlighting BioVie's progress and market opportunities.
Read more →BioVie Announces Full Enrollment of the ADDRESS-LC Trial of Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID
BioVie Inc. has announced the full enrollment of its ADDRESS-LC Phase 2 trial, which evaluates bezisterim for treating neurological symptoms associated with Long COVID. The study is fully funded by a U.S. Department of War grant and aims to assess the drug's efficacy in alleviating cognitive impairment and fatigue. Topline data is expected to be released in late summer 2026.
Read more →BioVie Announces Completion of Phase 2 SUNRISE-PD Trial in Early-Stage Parkinson’s Disease
BioVie Inc. has completed the last patient evaluation visit for its Phase 2 SUNRISE-PD trial, which assesses the drug bezisterim in early-stage Parkinson's disease. The trial aimed to evaluate motor and non-motor endpoints and will now enter the closeout phase, with topline results anticipated in Q3 2026. The study utilized a hybrid decentralized design to enhance patient participation.
Read more →BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease ahead of Topline Data in 2Q26, on May 7, 2026
BioVie Inc. will host a virtual KOL event on May 7, 2026, to discuss the Phase 2 study of bezisterim for Parkinson's disease. The event will feature Dr. Suzanne de la Monte, who will elaborate on bezisterim's mechanism of action. The drug has shown promise in improving motor control in patients and is being evaluated for its potential benefits in neurodegenerative diseases.
Read more →BioVie Announces Abstract Accepted for Presentation at the 2026 American Academy of Neurology Annual Meeting
BioVie Inc. announced that an abstract from its SUNRISE-PD study on bezisterim has been accepted for presentation at the 2026 American Academy of Neurology Annual Meeting. The abstract will summarize initial data on patients with Parkinson's Disease and will be presented during a session focused on emerging therapeutics. Topline results from the study are anticipated in mid-2026.
Read more →BioVie Announces Abstract Accepted for Presentation at AD/PD 2026
BioVie Inc. announced that its abstract on bezisterim (NE3107) for Parkinson's disease has been accepted for presentation at the AD/PD 2026 conference in Copenhagen. The abstract summarizes initial data from the SUNRISE-PD study, which evaluates bezisterim's efficacy in early Parkinson's patients. Topline results are anticipated in mid-2026, highlighting the company's ongoing research in neurodegenerative diseases.
Read more →Join Biovie’s Exclusive Live Investor Webinar and Q&A Session on March 4
BioVie Inc. is inviting investors to a webinar on March 4, 2026, featuring CEO Cuong Do. The session will cover the investigational drug bezisterim, which targets neuroinflammation and insulin resistance, and the orphan drug BIV201 for liver disease. The company is advancing multiple clinical programs with potential late-stage developments.
Read more →BioVie Announces Abstracts Accepted for Presentation at the 2026 American College of Psychiatrists Annual Meeting
BioVie Inc. announced the acceptance of two abstracts for its lead candidate, bezisterim, at the 2026 American College of Psychiatrists annual meeting. The abstracts focus on bezisterim's effects on Alzheimer's disease and Long COVID. The company has seen promising results in previous trials for Parkinson's disease and continues to explore bezisterim's therapeutic potential.
Read more →BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson’s Disease
BioVie Inc. has successfully completed the enrollment of 60 participants in its Phase 2 SUNRISE-PD clinical trial, which is assessing the efficacy of bezisterim for early Parkinson's disease. This study focuses on individuals who have not previously received treatment with carbidopa/levodopa, utilizing a hybrid trial design to improve patient access. With topline results expected in the first half of 2026, the trial aims to explore how bezisterim may influence the progression of Parkinson's symptoms. The company's efforts were supported by prominent advocacy organizations in the Parkinson's community.
Read more →BioVie to Host Live Investor Webinar and Q&A on Oct. 8
BioVie Inc. will host a live investor webinar on October 8, 2025, to discuss its innovative drug therapies for neurological diseases. CEO Cuong Do will present findings on bezisterim, which shows promise in treating Alzheimer’s and Parkinson’s diseases. The session will also cover BIV201, an orphan drug candidate for liver cirrhosis. A Q&A will follow the presentation.
Read more →BioVie Highlighted ADDRESS-LC Phase 2 Trial Design Exploring Bezisterim for the Treatment of Neurological Symptoms of Long COVID at Keystone Symposia on Long COVID and Other Post-Acute Infection Syndromes
BioVie Inc. announced the presentation of its ADDRESS-LC Phase 2 trial design at the Keystone Symposia. The trial evaluates bezisterim's efficacy in treating neurological symptoms of Long COVID, a condition affecting millions. The study is fully funded by the U.S. Department of Defense and aims to address significant unmet medical needs.
Read more →BioVie Inc. Announces Closing of $12 Million Public Offering
BioVie Inc. has successfully closed a $12 million public offering, selling 6 million units at $2.00 each. The offering included warrants that are now listed on the Nasdaq Capital Market. The funds raised will be utilized for working capital and general corporate purposes. The company is focused on developing therapies for chronic conditions, including liver disease and neurodegenerative disorders.
Read more →BioVie Inc. Announces Pricing of $12 Million Public Offering
BioVie Inc. has announced the pricing of its $12 million public offering, which includes 6,000,000 units priced at $2.00 each. The offering is set to close on August 11, 2025, and proceeds will be used for working capital and general corporate purposes. The warrants included in the offering are expected to trade on the Nasdaq Capital Market.
Read more →BioVie Presented Data Highlighting that Patients Treated with Bezisterim Potentially Experienced an Age Deceleration Advantage Compared to Placebo on 10 Different Biological Clocks at the 2nd World Conference on Aging and Gerontology
BioVie Inc. presented findings at the 2nd World Conference on Aging and Gerontology, indicating that bezisterim may decelerate biological aging in Alzheimer's patients compared to placebo. The drug targets inflammation and has shown promise in improving healthspan. Ongoing studies aim to further explore its efficacy in Alzheimer's and other neurodegenerative diseases.
Read more →