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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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RedChip Companies will air interviews with Rail Vision (NASDAQ:RVSN) and BioVie, Inc. (NASDAQ:BIVI) on The RedChip Small Stocks Big Money® Show on Bloomberg TV this Saturday, December 23, at 7 p.m. Eastern Time (ET). Rail Vision is a company at the forefront of an evolution in train safety, providing AI-based detection systems for obstacle identification on and near tracks. Knorr Bremse, a key strategic investor, has invested $25M across two investment cycles. BioVie is a clinical-stage company developing transformative therapies for neurodegeneration and liver disease, with positive trending data from a Phase 3 trial in Alzheimer's and Parkinson's. The company plans to launch Phase 3 trials in 2024 and has multiple other efforts underway that may create additional catalysts.
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BioVie Inc. (NASDAQ: BIVI) announced positive analysis of unblinded, topline efficacy data from its Phase 3 clinical trial of NE3107 in the treatment of mild to moderate Alzheimer’s Disease. The trial showed NE3107’s treatment advantage over placebo to potentially be equal to or greater than data reported from clinical trials for the approved medications for AD without the associated safety concerns. The trial started during the COVID-19 pandemic, enrolling 439 patients through 39 sites. The trial identified significant deviations from protocol and Good Clinical Practice (GCP) violations at 15 sites, leading to exclusions and referral to the U.S. Food and Drug Administration (FDA) Office of Scientific Investigations (OSI) for further action. After exclusions, 81 patients remained in the Modified Intent to Treat (MITT) population, 57 of whom were in the Per-Protocol population.
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BioVie Inc. (NASDAQ: BIVI) announces positive clinical safety data from Phase 2b study of BIV201, a continuous infusion of terlipressin, in combination with standard of care for patients with refractory ascites due to cirrhosis. The data supports the acceleration of BIV201 into Phase 3 trials, with a commitment to commence in Q2 2024. The results show favorable safety profile and well-tolerated combination with standard of care, encouraging further development and investigation in confirmatory trials.
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BioVie Inc. announced the participation of its management team in the Truist Securities BioPharma Symposium to be held in New York on November 8-9, 2023. The symposium will include a panel presentation on 'Exploring Late-Stage New Modalities in Alzheimer's Disease' and one-on-one investor meetings. For more information, contact Truist Securities.
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BioVie Inc. announced that its management will host a conference call and webcast on November 1, 2023, to review recent data on NE3017 presented at the CTAD conference. The call will be led by BioVie's President and CEO Cuong Do, Chief Medical Officer Dr. Joseph Palumbo, and Dr. Steven Arnold of Harvard Medical School.
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BioVie presents blinded data on cognitive, biomarker, and imaging findings from Phase 3 trial of NE3107 in Alzheimer's Disease at CTAD. Statistically significant population changes observed in cognitive and functional assessments. Reduction in amyloid burden observed. Increases in insulin and beta cell function without hypoglycemia. Increased FDG-PET SUVRs suggestive of reduced amyloid burden. Unblinded, topline data expected in late November or early December.
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BioVie to present blinded data on Phase 3 clinical trial of NE3107 for Alzheimer's Disease at CTAD conference
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BioVie Inc. announces completion of Phase 3 study for NE3107 in Alzheimer's Disease patients.
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BioVie's lead drug candidate aims to treat neurodegenerative disease by targeting inflammation.
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FAQ

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

The current stock price of BioVie (BIVI) is $3.05 as of November 22, 2024.

What is the market cap of BioVie (BIVI)?

The market cap of BioVie (BIVI) is approximately 54.0M.

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

54.02M
15.34M
13.69%
9.99%
10.82%
Biotechnology
Pharmaceutical Preparations
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United States of America
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