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BioVie Inc.

BIVI
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$1.39
▲ +0.05 · +3.91%

Financials

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52W LOW $0.8252W HIGH $3.79
Volume
204.86 K
Value Traded
1.36 M
Short % Float
12.73%
-3.47%Week
-27.98%1 Month
-15.24%3 Month
+0.72%6 Month
-99.89%5 Year
-99.98%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
11.75 M
EPS (TTM)
-2.59
P/E Ratio
-
Ent. Value
2.77 M
Total Shares
8.45 M
Float Shares
8.22 M
Insiders
3.63%
Institutions
25.54%

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 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

BIVI Catalyst Timeline

Dated clinical, regulatory and corporate events for BioVie Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for BioVie Inc.

312Total events
5Upcoming
66Tier-1 (high impact)
2018 to 2026Coverage

Upcoming catalysts 2

T2End Of Phase 2 Meeting
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bezisterim
T2FDA Feedback Received
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bezisterim

Event history 50

▲Topline ReadoutbezisterimClinical Data
BioVie announces topline results from Phase 2 ADDRESS-LC trial of bezisterim in Long COVID
Long COVIDsource ↗
▲Primary Endpoint MetbezisterimClinical Data
Statistically significant improvements in pre-specified high-symptom-burden subgroups
Long COVIDsource ↗
▲Safety Data UpdatebezisterimClinical Data
Bezisterim safety and tolerability similar to placebo in ADDRESS-LC
Long COVIDsource ↗
●R&D DayPresentation
BioVie conference call to discuss ADDRESS-LC results
●Oral PresentationbezisterimPresentation
Conference call to discuss ADDRESS-LC topline results
Long COVIDsource ↗
▲Subgroup AnalysisbezisterimClinical Data
Pre-specified subgroup analyses show statistically significant improvements in high symptom burden patients
Long COVIDsource ↗
◆End Of Phase 2 MeetingbezisterimFDA Meeting
End-of-Phase 2 Meeting requested with FDA
Parkinson's diseasesource ↗
◆Topline ReadoutbezisterimClinical Data
Topline results for ADDRESS-LC anticipated before end of September 2026
Long COVIDsource ↗
◆End Of Phase 2 MeetingbezisterimFDA Meeting
BioVie requests End-of-Phase 2 Meeting with FDA for bezisterim in Parkinson's disease
Parkinson's diseasesource ↗
●Trial CompletionbezisterimTrial
Last on-treatment visit of ADDRESS-LC completed
Long COVIDsource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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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 %
2026-09-15bezisterim (NE3107) Phase 2 topline data readout Phase 2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D26 / 100
Pipeline Score
$1M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.1x
rNPV / MCap
Top 78%
Micro Cap
(rank 515 of 660)
Percentile Rank
BioVie Inc. faces pipeline headwinds (26/100), with $429M risk-adjusted pipeline value, led by NE3107 in Alzheimer Disease (Phase 3), but cash runway is a concern.
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
NE3107 Small moleculeCompletedNCT05227820Alzheimer DiseasePhase 3 COMPLETED 462Aug 20, 2022
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Clinical Trial Results

Readouts, endpoints and source filings for every BIVI program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
bezisterim Long COVIDPhase 22026-09-1521 out of 22 endpoints showing favorable trendsRead MoreBioVie Announces Topline Results from Phase 2 ADDRESS‑LC Trial Evaluating Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVIDRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Palumbo Joseph MOfficer (Chief Medical Officer)Buy 4,843 6,036 held$2.16 08/28/2026
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Hedge Fund 13F Activity

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)
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Shares held by hedge funds each quarter, and who bought or sold.

BIVI Institutional Ownership Trends

Options Data

Option Volume

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Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How BIVI ranks across every disease it competes in

Competitive Position is a premium feature
See how BIVI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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BIVI News

BIVI
Sep 15, 2026
BIVIPhases
▼ -14.6%on this 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 →
BIVI
Sep 14, 2026
BIVIConferences/Events
▼ -14.6%on this newsshared move

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 →
BIVI
Sep 8, 2026
BIVIPhases

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 →
BIVI
Aug 31, 2026
BIVIPhases
▲ +5.6%on this news

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 →
BIVI
Aug 6, 2026
BIVIPhases
▼ -33.8%on this news· ran to -51% by day 1

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 →
BIVI
May 27, 2026
BIVIConferences/Events

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 →
BIVI
May 26, 2026
BIVIPhases
▼ -5.3%on this newsshared move

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 →
BIVI
May 18, 2026
BIVIPhases

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 →
BIVI
Apr 27, 2026
BIVIConferences/Events
▲ +6%on this news

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 →
BIVI
Apr 14, 2026
BIVIConferences/Events
▲ +5.8%on this news

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.

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BIVI
Mar 12, 2026
BIVIConferences/Events

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 →
BIVI
Feb 23, 2026
BIVIConferences/Events

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 →
BIVI
Feb 12, 2026
BIVIConferences/Events

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 →
BIVI
Jan 8, 2026
BIVIPhases

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 →
BIVI
Sep 26, 2025
BIVIConferences/Events

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 →
BIVI
Aug 13, 2025
BIVIPhases

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 →
BIVI
Aug 11, 2025
BIVIGeneral
▼ -6.7%on this newsshared move

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 →
BIVI
Aug 8, 2025
BIVIGeneral
▼ -42.6%on this newsshared move

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 →
BIVI
Jul 24, 2025
BIVIConferences/Events
▼ -8.4%on this news

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 →

About BioVie Inc.

Carson City, NV 13 employees bioviepharma.com
Headquarters680 W NYE LANE, CARSON CITY, NV, 89703
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