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BioVie, Inc. - BIVI STOCK NEWS

Welcome to our dedicated page for BioVie news (Ticker: BIVI), a resource for investors and traders seeking the latest updates and insights on BioVie stock.

BioVie Inc. (OTC Pink: BIVI) is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies for chronic and debilitating conditions. The company's primary areas of research include chronic liver diseases, neurological disorders, and certain cancers.

BioVie's lead drug candidate, BIV201, targets ascites, a severe complication associated with advanced liver cirrhosis caused by hepatitis, non-alcoholic steatohepatitis (NASH), or alcoholism. Ascites affects approximately 100,000 Americans and has a high mortality rate of around 40% within two years of diagnosis. BIV201, based on the drug terlipressin, is currently entering a Phase 2 clinical trial in the US. Terlipressin is already approved in about 40 countries for treating liver cirrhosis complications, highlighting the potential of BIV201 to address a significant unmet medical need in the US. Notably, the FDA has not yet approved any drug specifically for ascites, and BIV201 has obtained orphan drug status.

Besides its liver disease program, BioVie is also advancing its NE3107 candidate, aimed at treating neurological and neuro-degenerative disorders. The company is conducting a Phase 3 randomized, double-blind, placebo-controlled study to evaluate NE3107 in patients with mild to moderate Alzheimer's disease. Additionally, NE3107 has shown promise in improving both motor and non-motor symptoms in Parkinson's disease, with significant improvements observed in patient trials.

BioVie has secured strategic investments from prominent investors, including Aspire Capital, Cuong Do (Global Strategy Lead for Samsung), and Hari Kumar (Founder of Adheron Therapeutics). These partnerships underscore the confidence in BioVie's innovative drug development pipeline.

Recent studies and presentations have highlighted the potential of NE3107 in addressing Alzheimer's and Parkinson's diseases. For instance, NE3107-treated patients exhibited improvements in cognitive and functional measures, biological age deceleration, and metabolic inflammation-driven systems dysregulation. These findings suggest that NE3107 could significantly impact core symptoms of these conditions by modulating inflammation and enhancing insulin sensitivity in the brain.

BioVie remains committed to advancing its clinical programs and delivering novel therapies to improve the lives of patients suffering from these challenging conditions.

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BioVie Inc. (NASDAQ: BIVI) has received FDA authorization for its Investigational New Drug (IND) application to evaluate bezisterim in a Phase 2 trial for treating neurological symptoms associated with long COVID. This milestone puts BioVie on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense and initiate the trial. The planned study will be a randomized, placebo-controlled, multicenter trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over a 3-month treatment period.

Long COVID affects about 5.5% of U.S. adults, with approximately 3.6 million people reporting significant activity modifications due to the illness. Bezisterim's potential to modulate inflammation by activating NF-kB and its ability to permeate the blood-brain barrier make it a promising candidate for addressing the underlying mechanisms of long COVID symptoms.

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BioVie Inc. (NASDAQ: BIVI) presented clinical data on bezisterim at the 11th Aging Research and Drug Discovery Meeting, revealing its potential to modulate inflammation and the biological aging process. Key findings include:

1. Patients treated with bezisterim experienced a 2-4 year age deceleration advantage compared to placebo.

2. Bezisterim modulated DNA methylation of proinflammatory genes and appeared to promote the transition of M1 proinflammatory to M2 anti-inflammatory macrophages.

3. The drug was associated with a 1.5 to 2.3 'fold enrichment' on gene control for hundreds of genes in pathways linked to neurodegenerative disorders and biological processes.

These results suggest bezisterim's potential to impact various age-related diseases and inflammation-related conditions.

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BioVie Inc. (NASDAQ: BIVI) announced a poster presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) in Copenhagen, Denmark. The presentation, titled 'Bezisterim Effects on Biological Age, Alzheimer's Epigenetics, and Neurologic Assessments', will showcase clinical data on bezisterim, focusing on its potential impact on longevity and the biological aging process.

Christopher L. Reading, BioVie's Senior VP of Alzheimer's Disease Program, will deliver the presentation on August 27, 2024. The company aims to highlight bezisterim's effects on biological age, gene expression, and measures of aging-related diseases. Detailed data and conclusions will be announced after the public presentation at the conference.

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BioVie Inc. (NASDAQ: BIVI) has announced alignment with the FDA for its SUNRISE-PD trial to evaluate bezisterim (NE3107) in Parkinson's disease. The trial will assess the drug's effect on motor and non-motor symptoms in approximately 60 patients naive to carbidopa/levodopa. The FDA recommended including the MDS-UPDRS Part II score as a primary endpoint, which is already part of the trial design as a secondary endpoint. BioVie plans to initiate patient screening in Q4 2024. This Phase 2 study aims to explore bezisterim's impact on newly diagnosed patients, complementing earlier trials and potentially establishing its applicability for the entire Parkinson's patient population.

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BioVie Inc. (NASDAQ: BIVI) has announced the implementation of a 1-for-10 reverse stock split of its issued and outstanding Class A common stock, effective August 6, 2024. The company's shares began trading on a split-adjusted basis on the same day, maintaining its listing on The Nasdaq Capital Market under the symbol "BIVI". This action follows the approval by BioVie stockholders at a Special Meeting held on July 29, 2024. The reverse split aims to adjust the company's share structure, potentially impacting its market capitalization and share price. Investors can find detailed information about the Special Meeting in the company's definitive proxy statement filed with the SEC on June 17, 2024, available on the SEC website and BioVie's corporate website.

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BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.

Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).

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BioVie presented the upcoming SUNRISE-PD Phase 2 trial design at ATMRD 2024, evaluating bezisterim (NE3107) on motor and non-motor symptoms in early Parkinson's disease patients. The trial will involve 60 participants, randomized to receive either bezisterim or placebo for 12 weeks. Key objectives include assessing motor symptom improvements, non-motor symptoms, and overall PD symptoms. In parallel, they presented Phase 2a data showing bezisterim's potential as an adjunctive therapy to carbidopa/levodopa, with significant improvements in motor functions and non-motor symptoms like sleep and restlessness. These findings support further evaluation in a larger trial. If successful, participants may join a future long-term safety study.

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BioVie and Mobilicom will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV, airing June 22 at 7 p.m. ET. BioVie's CEO, Cuong Do, discusses the company's late-stage clinical programs targeting neurodegeneration and liver disease, highlighting their lead asset, bezisterim, which has shown promising results in clinical trials for Parkinson's and Alzheimer's diseases. Key milestones include a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.

Mobilicom's CEO, Oren Elkayam, will talk about their investment opportunities. Mobilicom's products, like SkyHopper Datalinks and the ICE Cybersecurity Suite, have led to significant market penetration, with 50 customers in 18 countries. The company achieved 43% revenue growth and a 59% gross margin in 2023, ending the year with $8.4 million in cash, indicating a solid financial position to execute their strategic plans.

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BioVie announced two poster presentations at the ATMRD Congress in Washington, D.C., from June 21-25, 2024. The presentations will focus on the Phase 2 trial protocol for bezisterim (NE3107) in early Parkinson’s patients and its impact on motor and non-motor symptoms, specifically for those not yet treated with carbidopa/levodopa. The first poster will be displayed on June 22 from 5-5:30 p.m. EDT, outlining the study protocol. Another poster will be shown the same day from 4:20-4:50 p.m. EDT, featuring data on bezisterim’s effects when used alongside carbidopa/levodopa.

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BioVie (NASDAQ: BIVI), a clinical-stage company focused on neurological, neurodegenerative, and liver diseases, will host a live investor webinar on June 26, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Cuong Do, discussing the company's clinical pipeline, including bezisterim (formerly NE3107). Bezisterim has shown promising results in reducing inflammation, insulin resistance, and improving symptoms in Parkinson's and Alzheimer's diseases. Strategic priorities include a Phase 2b trial for Parkinson's in Fall 2024, a Phase 3 trial for Alzheimer's in mid-2025, and ongoing partnering discussions.

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FAQ

What is the current stock price of BioVie (BIVI)?

The current stock price of BioVie (BIVI) is $3.17 as of September 12, 2024.

What is the market cap of BioVie (BIVI)?

The market cap of BioVie (BIVI) is approximately 20.1M.

What does BioVie Inc. specialize in?

BioVie Inc. focuses on developing innovative drug therapies for chronic liver diseases, neurological disorders, and certain cancers.

What is BIV201?

BIV201 is a drug candidate targeting ascites, a severe complication of advanced liver cirrhosis. It is based on terlipressin and is entering Phase 2 clinical trials in the US.

What is NE3107?

NE3107 is a drug candidate aimed at treating neurological and neuro-degenerative disorders, including Alzheimer's and Parkinson's diseases. It is currently in Phase 3 trials for Alzheimer's.

Why is BIV201 significant?

BIV201 addresses a significant unmet medical need for treating ascites, a condition with a high mortality rate and no FDA-approved treatments in the US.

Who are some of BioVie's strategic investors?

BioVie has secured investments from Aspire Capital, Cuong Do, and Hari Kumar, highlighting the potential of its innovative therapies.

What recent achievements has BioVie made?

BioVie has advanced BIV201 to Phase 2 trials and conducted promising Phase 3 trials for NE3107, showing significant improvements in Alzheimer's and Parkinson's symptoms.

What are the primary focus areas of BioVie's research?

BioVie focuses on chronic liver diseases, neurological disorders, and certain cancers.

How does NE3107 work?

NE3107 works by modulating inflammation and enhancing insulin sensitivity in the brain, potentially slowing disease progression and improving symptoms.

What is the market potential for BIV201?

BIV201 has substantial market potential as it targets ascites, a condition affecting around 100,000 Americans with a high mortality rate and no FDA-approved treatments.

How can investors and media inquire about BioVie?

For investor relations, contact Bruce Mackle at LifeSci Advisors. For media inquiries, contact Melyssa Weible at Elixir Health Public Relations.

BioVie, Inc.

Nasdaq:BIVI

BIVI Rankings

BIVI Stock Data

20.06M
6.12M
39.63%
8.34%
1.43%
Biotechnology
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