BioVie Inc..
BIVI.US | Manufacture of pharmaceuticals, medicinal chemical and botanical products
BioVie Inc. is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies for the treatment of liver disease, neurodegenerative disorders, and cancer. Their pipeline includes investigational drug candidates targeting conditions such as ascites, non-alcoholic steatohep...Show More
Better Health for All
10
BioVie Inc. is a clinical-stage biopharmaceutical company entirely focused on developing drug therapies for serious conditions with high unmet needs, such as refractory ascites, Alzheimer's, Parkinson's, and Long COVID. Its entire business model is dedicated to health improvement, with all investment directed towards health innovation, including a $13.13 million grant from the U.S. Department of Defense for a Long COVID trial.
1
The company's drug candidates show potential for significant health benefits, with BIV201 reducing ascites fluid buildup by over 50% in those who completed treatment, and NE3107 showing a 4.66-year advantage in age deceleration in Alzheimer's patients and improving Parkinson's symptoms.
2
BIV201 was well-tolerated in trials with minimal adverse events, and bezisterim (NE3107) reported no drug-related adverse events in Parkinson's trials.
3
BioVie employs innovative trial designs, such as a decentralized approach for its Parkinson's trial, to improve access for patients with limited mobility and geographic constraints.
4
The company demonstrates risk transparency by reporting significant Good Clinical Practice (GCP) violations and protocol deviations at 15 sites in its NE3107 Alzheimer's Phase 3 trial to the FDA, and uses independent firms for data analysis and quality control.
5
Furthermore, BioVie partnered with the American Liver Foundation for an educational campaign on liver cirrhosis.
6
However, the company's clinical trial ethics are significantly impacted by these widespread GCP violations and protocol deviations, which led to the termination of the BIV201 Phase 2b trial and the failure of the NE3107 Alzheimer's Phase 3 trial.
7
The company also initiated a trial for Long COVID, responding to a public health emergency.
Fair Money & Economic Opportunity
0
BioVie Inc. is a clinical-stage biopharmaceutical company. The provided articles detail its stock offerings, SEC filings, and a class-action lawsuit concerning a clinical trial.
1
None of the articles contain information about the company offering lending, insurance, or other financial services to consumers or underserved populations. Therefore, all KPIs related to 'Fair Money & Economic Opportunity' are not applicable to BioVie Inc.'s core business as evidenced by the provided information.
Fair Pay & Worker Respect
0
No evidence available to assess BioVie Inc. on Fair Pay & Worker Respect.
Fair Trade & Ethical Sourcing
0
No evidence available to assess BioVie Inc. on Fair Trade & Ethical Sourcing.
Honest & Fair Business
0
No evidence available to assess BioVie Inc. on Honest & Fair Business.
Kind to Animals
0
No information relevant to the 'Kind to Animals' value or any of the specified KPIs was found in the provided articles.
1
The articles either stated an inability to access external websites or indicated that their content, which focused on corporate governance, did not contain the requested data points.
No War, No Weapons
0
BioVie Inc. received a grant of up to $13.1 million from the U.S. Department of Defense for a clinical trial to evaluate Bezisterim (NE3107) for the treatment of neurological symptoms of Long COVID.
1
Bezisterim is an anti-inflammatory and insulin sensitizer.
2
There is no evidence that this grant constitutes revenue from arms or defense contracts, nor is there any indication that the drug or its development involves dual-use technology with military applications or exposure to controversial weapons.
Planet-Friendly Business
0
No specific, concrete data points were found across the provided articles for any of the Planet-Friendly Business KPIs. The articles primarily focus on company financials, legal proceedings, and drug development pipeline. While one article mentions an overall Environmental Score of 4.33, this is an aggregated rating and not a specific, quantitative data point required by the rubric's KPIs (e.g., total emissions, percentage of renewable energy, or water use per revenue).
1
Respect for Cultures & Communities
0
No specific, quantifiable evidence was found in the provided articles for any of the KPIs related to 'Respect for Cultures & Communities'. While BioVie Inc. has a Chief Social Impact Officer and mentions 'Social Impact Partners' and 'collaborative partners' in general terms,
1
the articles do not provide concrete data points such as the number of formal partnerships with indigenous or local community groups, percentage of revenue reinvested in local community development, or any other specific metrics defined in the rubric.
Safe & Smart Tech
-30
BioVie Inc. reported no material cybersecurity incidents or unauthorized data use incidents in the last fiscal year.
1
The company's policies and processes are informed by NIST and other industry standards.
2
Users can request removal from the company's database.
3
However, the company faces allegations of potential scientific misconduct and non-compliance with Good Clinical Practice (GCP) regulations, including improper oversight and significant deviations from protocol at multiple sites, which has led to the FDA's Office of Scientific Integrity being alerted.
4
Zero Waste & Sustainable Products
-50
BioVie has implemented a plastic neutrality initiative, committing to offset all plastic it puts on the market starting in 2025 by commissioning a third party to remove an equivalent amount of plastic waste from the environment.
1
The company encourages its suppliers to achieve plastic neutrality, but this is not a formal requirement.
2