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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.

Overview

BioVie Inc (BIVI) is a clinical-stage biotechnology company dedicated to pioneering novel drug therapies aimed at addressing critical unmet needs in chronic liver diseases, neurodegenerative disorders, and specific cancers. Rooted in advanced research and clinical innovation, the company combines deep scientific expertise with rigorous testing to bring forward therapies that target life-threatening complications, notably ascites in liver cirrhosis patients, as well as conditions related to Alzheimer’s and Parkinson’s diseases. Using a strategic blend of scientific insight and clinical research, BioVie Inc. leverages its pipeline assets to address conditions that have long challenged conventional treatment methodologies.

Clinical Programs and Drug Development

At the heart of BioVie Inc.’s mission is the development of two key clinical programs that demonstrate the company's diversified approach within the biotechnology sector:

  • BIV201: Designed to mitigate the complications associated with chronic liver disease, BIV201 targets patients suffering from ascites—a condition that emerges from advanced cirrhosis due to hepatitis, non-alcoholic steatohepatitis (NASH), or alcohol-related liver damage. With a mechanism rooted in novel adaptations of terlipressin, a drug mechanism recognized outside the United States, BIV201 has been structured to offer a treatment where no FDA-approved alternatives exist, thus addressing a significant unmet medical need. The drug candidate has achieved orphan drug status, a marker of its potential impact in a smaller, yet critically underserved, patient population.
  • Bezisterim (formerly NE3107): This asset is being investigated in rigorous clinical trials for its potential benefits in neurodegenerative and inflammatory conditions. In studies conducted under stringent, randomized, double-blind conditions, bezisterim has shown promise in modulating key inflammatory markers and pathways, including NFkB activation and TNFα production. The compound’s action is designed to reduce inflammation and improve patient outcomes in disorders such as Alzheimer’s disease and Parkinson’s disease, thereby underscoring BioVie Inc.’s commitment to tackling complex, multi-factorial diseases with a methodical, evidence-based approach.

Operational Model and Research Framework

BioVie Inc. capitalizes on a robust clinical research framework that includes multi-center, placebo-controlled studies, ensuring that data obtained is both reliable and replicable. This comprehensive approach spans several phases of clinical research, with the company continually adapting its protocols to align with both scientific advancements and regulatory standards. The integration of strategic funding from notable investors and partners underscores its commitment to maintaining high standards in clinical research while ensuring that financial resources are dedicated to furthering key trials and associated studies.

Market Position and Strategic Advantages

The company occupies a unique niche in the competitive landscape. Unlike many large pharmaceuticals that focus on incremental improvements to established therapies, BioVie Inc. invests heavily in treatments that confront severe and often neglected clinical conditions. Its emphasis on orphan drugs and compounds that have historically been approved in markets outside the United States positions it as an innovator with a potential first-in-class offering. The dual focus on both liver disease complications and neurodegenerative disorders enhances its research portfolio, ensuring diversification and a broad applicability of its scientific findings.

Scientific and Clinical Expertise

Underpinned by expert-led research teams, BioVie Inc. demonstrates a comprehensive understanding of both molecular pharmacology and clinical trial methodologies. Its strategic choice of compounds is evidence of a sophisticated process that involves evaluating inflammatory pathways, cellular signaling mechanisms, and biomarkers indicative of disease progression. By targeting key regulators such as ERK, NFkB, and TNFα, the company’s therapies are aimed at mitigating underlying pathological processes. This deliberate focus on mechanistic insights enables BioVie Inc. to bring forward treatments that do more than simply alleviate symptoms—they aim to modify disease progression at a fundamental level.

Partnerships and Collaborative Research

The operational blueprint at BioVie Inc. includes active engagement with strategic investors and thought leaders in the biopharma industry. Collaborative efforts not only bolster the company’s capital base but also enhance its research and development capabilities. These partnerships play a critical role in streamlining clinical trial operations, facilitating regulatory discussions, and expanding geographic rights and market presence. The interplay between internal scientific innovation and external strategic input amplifies the efficacy and reach of its clinical programs.

Key Differentiators in a Competitive Landscape

BioVie Inc. distinguishes itself through both its focused research priorities and its methodical approach to clinical development. While the broader biopharmaceutical landscape is populated with companies targeting a wide array of conditions, BioVie Inc. maintains a concentrated focus on diseases where treatment options are extremely limited. The company’s clear emphasis on unmet needs within liver diseases and neurodegenerative disorders ensures that its research is both impactful and finely tuned to market demands. This focus, coupled with robust dossier preparation and adherence to strict trial protocols, enhances its credibility and positions it as a trustworthy source of innovation for clinicians and researchers alike.

Scientific Rigor and Efficacy

Every investigational asset is subjected to rigorous preclinical and clinical evaluation processes, which are core to BioVie Inc.'s operational strategy. The design of its clinical trials is evidentially rooted in a deep understanding of disease pathology and pharmacodynamics. By employing measures like double-blind, placebo-controlled studies, BioVie Inc. reinforces the reliability of its findings and the potential efficacy of its therapies. This scientific rigor is reflected in the meticulous way in which the company collects and analyzes data, thereby ensuring that every claim regarding its drug candidates is substantiated with empirical evidence.

Regulatory Strategy and Compliance

In navigating the complex regulatory frameworks that govern clinical drug development, BioVie Inc. has structured its research to align with international and domestic guidelines. Adoption of best practices in clinical trial management, combined with transparent protocols and continuous dialogue with regulatory agencies, signifies the company’s commitment to meeting stringent compliance standards. This orientation towards regulatory excellence not only secures the validity of its clinical data but also enhances investor and stakeholder confidence by demonstrating a firm commitment to ethical and effective drug development processes.

Conclusion

In summary, BioVie Inc. represents a dynamic force in the biotechnology arena, characterized by its innovative approach to treating some of the most challenging medical conditions of our time. By addressing both chronic liver diseases—through its novel candidate BIV201—and exploring neurodegenerative disorders with bezisterim, the company has established a multi-faceted research portfolio that is positioned to make significant scientific contributions. Its blend of rigorous clinical protocols, strategic investor support, and steadfast adherence to industry best practices underpins a vision where unmet clinical needs are met with carefully crafted therapeutic solutions.

This in-depth analysis conveys the company’s operational methods, scientific rationale, and comprehensive trial design, providing investors and industry professionals with a clear understanding of BioVie Inc.’s value proposition. By presenting a logical hierarchy of detailed information—from its core clinical innovations to scientific integrity and regulatory adherence—this overview serves as a reliable resource for those seeking an expert examination of the company’s ongoing efforts to redefine therapeutic interventions in its core areas of focus.

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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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FAQ

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

The current stock price of Biovie (BIVI) is $0.775 as of April 4, 2025.

What is the market cap of Biovie (BIVI)?

The market cap of Biovie (BIVI) is approximately 14.7M.

What is the core focus of BioVie Inc?

BioVie Inc is a clinical-stage biotechnology company focused on developing novel drug therapies for chronic liver disease complications, neurodegenerative disorders, and certain cancers. Its work addresses critical unmet medical needs using innovative clinical research.

How does BioVie Inc generate its revenue?

The company’s revenue model is primarily driven by its clinical-stage development programs. While it has not yet commercialized products, its funding is supported through strategic partnerships and investor backing for its advanced clinical trials.

What makes BioVie Inc's approach unique compared to other biopharmaceutical companies?

BioVie Inc distinguishes itself with a targeted focus on conditions that have limited treatment options, such as ascites in liver cirrhosis and neurodegenerative disorders. Its integration of orphan drug status with rigorous clinical protocols underscores its unique value proposition.

What are the primary drug candidates under development?

The company is developing BIV201 for complications related to chronic liver disease and bezisterim (formerly NE3107) for neurodegenerative and inflammatory conditions. Both candidates are subjected to rigorous clinical evaluation to ensure efficacy and safety.

How does BioVie Inc ensure the reliability of its clinical data?

BioVie Inc employs a comprehensive research framework using randomized, double-blind, placebo-controlled, multicenter studies. This methodical approach reinforces the reliability of its clinical data and supports robust evaluation of its drug candidates.

What regulatory standards does BioVie Inc adhere to?

The company aligns its clinical trials with both international and domestic regulatory guidelines. Its proactive engagement with regulatory authorities ensures the compliance and integrity of all research processes and study protocols.

Who are the typical stakeholders interested in BioVie Inc?

Investors, industry analysts, and medical researchers are among the key stakeholders. They value the company’s scientific rigor, innovative approach to addressing unmet medical needs, and its structured clinical development strategy.

How does BioVie Inc differentiate its clinical programs?

BioVie Inc differentiates its clinical programs through its focused approach on specific diseases such as liver disease complications and neurodegenerative disorders. The use of advanced research methodologies and strategic partnerships further enhances its differentiation.
Biovie Inc

Nasdaq:BIVI

BIVI Rankings

BIVI Stock Data

14.73M
15.97M
13.09%
4.27%
8.88%
Biotechnology
Pharmaceutical Preparations
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United States
CARSON CITY