BioVie to Present New Bezisterim Findings in Parkinson’s Disease and Long COVID at the 2026 American Neurological Association Annual Meeting

The completed Parkinson’s trial reported greater improvements than placebo across several clinical measures.

Rhea-AI Summary

BioVie (BIVI) will present results from two Phase 2 bezisterim trials at the American Neurological Association meeting, October 17–20, 2026.

The ADDRESS-LC Long COVID poster is scheduled for October 18, and the SUNRISE-PD Parkinson’s disease poster for October 19 in San Diego. SUNRISE-PD enrolled 57 patients with early-stage disease who had not previously received carbidopa/levodopa. Topline results showed improvements in inflammation biomarkers and greater improvements than placebo across measures of daily functioning, motor symptoms and non-motor symptoms. ADDRESS-LC enrolled approximately 200 patients to evaluate brain fog, fatigue and other chronic neurological symptoms. Bezisterim remains investigational.

3 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 0 points

How the balance works

Positive

• Moderate pointSUNRISE-PD topline results showed greater improvements than placebo in daily functioning, motor symptoms and non-motor symptoms.
• Moderate pointAlzheimer’s Phase 2 and Phase 3 preliminary data suggest improvements in cognition and biomarkers.
• Minor pointSUNRISE-PD bezisterim-treated patients showed improvements in inflammation biomarkers and biomarkers associated with cellular health and neuronal integrity.

Negative

• None.

Argus 15 min delay 1 alert

-1.58% vs previous close $1.18 last price 0.8x rel. volume Open Argus

Details

Market Reaction – BIVI

$1.16 – $1.25 Day Range

$10.25M Market Cap

On Oct 14, the day this news came out, the latest delayed price for BIVI is 1.58% below the previous close. The latest delayed price is $1.18.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Terms

phase 2, placebo-controlled, blood-brain barrier, nfκb

4 terms

phase 2 medical

"ADDRESS-LC Phase 2 trial in Long COVID"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

placebo-controlled medical

"Double-Blind, Placebo-Controlled Study of the Efficacy and Safety"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

blood-brain barrier medical

"crosses the blood-brain barrier"

A protective barrier of tightly packed cells and supporting tissue that controls what substances in the blood can enter the brain, acting like a security checkpoint that keeps out most pathogens and many drugs while allowing essential nutrients through. For investors, the barrier matters because whether a therapy can cross or safely bypass it often determines clinical success, regulatory approval and commercial potential for treatments of brain disorders.

nfκb medical

"neuroinflammation (ERK, NFκB, TNFα)"

nfκb is a protein complex that acts like a master switch inside cells, turning on genes that drive inflammation, immune responses and cell survival when the body senses stress or infection. Investors care because many therapies, diagnostics and safety assessments target or measure this switch; changes in nfκb activity can indicate potential drug opportunities, predict side‑effect risks, or serve as a biomarker that affects a drug candidate’s development value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

CARSON CITY, Nev., Oct. 14, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that two abstracts detailing results from the Company’s ADDRESS-LC Phase 2 trial in Long COVID, and SUNRISE-PD Phase 2 trial of bezisterim in Parkinson’s Disease have been accepted for presentation at ANA2026, the annual meeting of the American Neurological Association.

Results of the two studies will be presented as posters during the conference. ANA2026 will be held in San Diego, CA from October 17-20, 2026.

Long COVID — ADDRESS-LC
Title: Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Bezisterim (NE3107) in Long COVID (ADDRESS-LC)
Authors: Penelope Markham (BioVie), Michael J. Peluso (UCSF), Christopher Reading (BioVie), Clarence Ahlem (BioVie), Stephen O’Quinn (Perissos), Navid A. Samad (Samad Consulting), Jeffrey Zhang (Princeton Pharmatech), Joseph M. Palumbo (BioVie)
Date: Sunday, October 18, 2026; Time: 5:30–7:00 PM

Parkinson’s disease — SUNRISE-PD
Title: Bezisterim (NE3107) in Early Parkinson’s Disease (SUNRISE-PD):
Initial Results and Observations from a Phase 2 Hybrid Design Trial
Authors: Authors: Joseph Palumbo (BioVie); Clarence Ahlem (BioVie); Christopher L. Reading (BioVie); Stephen O’Quinn (Perissos); Jeffrey Zhang (Princeton Pharmatech); Mark Stacy (Medical University of South Carolina)
Date: Monday, October 19, 2026; Time: 5:30–7:00 PM

About Bezisterim

Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD).

In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms.

For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other chronic neurological symptoms associated with LC. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation, a pathway that bezisterim has been shown to modulate.

In AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD.

About BioVie Inc.

BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead investigational drug candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for Long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue.

In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit www.bioviepharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate," "intend," "plan," "believe," "seek," "estimate," "will," "project," “potential,” “may,” or words of similar meaning. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. The Phase 2 ADDRESS-LC trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.

For Investor Relations Inquiries:
        
Contact:
Chuck Padala
Managing Director, LifeSci Advisors, LLC
chuck@lifesciadvisors.com

For Media Inquiries:
        
Contact:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will BioVie present its bezisterim trial results at ANA2026?

BioVie will present the ADDRESS-LC Long COVID poster on October 18, 2026, and the SUNRISE-PD Parkinson’s disease poster on October 19, 2026. Both sessions run from 5:30–7:00 PM during the American Neurological Association annual meeting in San Diego.

What did BioVie’s SUNRISE-PD trial show for bezisterim?

Topline SUNRISE-PD results showed greater improvements than placebo across measures of daily functioning, motor symptoms and non-motor symptoms. Bezisterim-treated patients also showed improvements in blood-based inflammation markers and biomarkers associated with cellular health and neuronal integrity. The completed Phase 2 trial enrolled 57 patients with early-stage Parkinson’s disease.