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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 to present baseline data from Phase 3 study on NE3107 for Alzheimer's disease at ADA conference
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BioVie Inc. (NASDAQ: BIVI) announced that a data abstract from its Phase 2 open-label trial of NE3107 in degenerative dementias has been accepted for presentation at the 78th Annual Scientific Convention of the Society of Biological Psychiatry in San Diego from April 27-29, 2023. The study titled Effects of NE3107 on Depression and Multimodal Outcomes in a Phase 2, Open-Label Study in Patients with Cognitive Decline Due to Degenerative Dementias will be presented by Nily Osman, MD. NE3107 is designed to inhibit inflammatory activation linked to neurodegenerative disorders like Alzheimer's and Parkinson's diseases. The company is also conducting a pivotal Phase 3 study to evaluate NE3107 in Alzheimer's patients. Additionally, BIV201, a continuous infusion terlipressin, is being assessed in a Phase 2b study for refractory ascites due to liver cirrhosis.

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BioVie, a clinical-stage company focused on innovative drug therapies for neurological disorders, announced data from its Phase 2 trials of NE3107 for degenerative dementias and Parkinson’s Disease. These abstracts will be presented at the 2023 American Academy of Neurology Annual Meeting, taking place April 22-27, 2023. Notable presentations include:

  • Multi-Modal Correlation Analyses: April 25, 8:00-9:00 am ET
  • Clinical Outcomes Study: April 25, 11:45 am-12:45 pm ET
  • Safety and Efficacy Study: April 23, 8:00-9:00 am ET

BioVie is also advancing its Phase 3 study of NE3107 in Alzheimer’s patients and conducting a Phase 2b study for its liver disease treatment, BIV201. The latter has received FDA Fast Track designation.

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ORLANDO, FL / ACCESSWIRE / March 24, 2023 / RedChip Companies will feature BioVie Inc. (NASDAQ:BIVI) in upcoming interviews on The RedChip Money Report® airing on Bloomberg TV on March 25 at 7 p.m. Eastern Time (ET). The program reaches approximately 73 million households in the U.S. BioVie is a clinical-stage company focused on innovative drug therapies for neurological disorders and liver disease. Its key drug candidates include NE3107 for Alzheimer's and Parkinson's diseases, and BIV201 for liver cirrhosis, both under ongoing clinical evaluations. Watch the interviews at BioVie Interview Access.

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BioVie Inc. (NASDAQ: BIVI) announced that data from its Phase 2 trial of NE3107 in Parkinson's Disease will be presented at the AD/PD 2023 conference in Gothenburg, Sweden, from March 28 to April 1, 2023. The oral presentation will discuss the Safety, Tolerability, and Efficacy of NE3107 in patients treated with levodopa/carbidopa. Additionally, a poster presentation will cover the pharmacokinetic profile of NE3107. The trial results indicated that NE3107 may improve motor control without causing adverse events. BioVie is also conducting a Phase 3 study for NE3107 in Alzheimer's disease and a Phase 2b study for BIV201 in patients with liver cirrhosis.

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BioVie Inc. (NASDAQ: BIVI) is hosting a virtual event, BioVie Day, on March 23, 2023, at 10 a.m. Eastern Time, to discuss its research in neurological and liver diseases. The session will cover chronic inflammation's role in disease, updates on clinical programs for Alzheimer’s and Parkinson’s, and the company's regulatory and commercialization strategies.

BioVie is advancing its drug candidates, including NE3107 for Alzheimer’s and Parkinson’s, and BIV201 for liver cirrhosis, both of which are in critical phases of clinical trials. Investors are encouraged to register for the event to gain insights into the company’s future direction.

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BioVie Inc. (NASDAQ: BIVI) announced a pause in patient enrollment for its Phase 2b clinical trial of BIV201, aimed at treating refractory ascites. Initial results from 15 patients showed a 34% reduction in ascites fluid after 28 days of treatment, significantly outperforming those receiving standard care. Notably, patients who completed treatment experienced a 53% reduction in ascites fluid, indicating the potential of BIV201 as a treatment option. The drug has received Orphan Drug and Fast Track designations from the FDA, and the company plans to discuss progressing to a pivotal Phase 3 trial.

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BioVie Inc. (NASDAQ: BIVI) announced its management team's participation in the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 13-15, 2023. The virtual presentation will take place on March 15, 2023, at 12:40 PM ET, featuring one-on-one investor meetings. BioVie is focused on developing innovative drug therapies for neurological disorders, including Alzheimer's and Parkinson's diseases, and advanced liver disease. Their drug candidate NE3107 is undergoing pivotal trials for Alzheimer's, while BIV201 is in a Phase 2b study for liver cirrhosis. The company aims to improve patient outcomes with its groundbreaking therapies.

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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

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54.02M
15.34M
13.69%
9.99%
10.82%
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