BioVie Completes Enrollment in Bezisterim Trial for Long COVID
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Source: NASDAQ.COM
- Trial Enrollment Completed: BioVie Inc. announced the completion of enrollment in its Phase 2 ADDRESS-LC trial for Bezisterim, targeting the neurological symptoms of Long COVID affecting approximately 15 million people in the U.S., indicating significant progress in addressing this unmet medical need.
- Drug Mechanism and Applications: Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier to modulate key neuroinflammatory pathways, aimed at alleviating symptoms in patients with Long COVID, Alzheimer's, and Parkinson's disease, showcasing its broad clinical application potential.
- Trial Design and Funding: The trial is a randomized, placebo-controlled, multicenter study fully funded by the U.S. Department of War, primarily assessing the safety and efficacy of Bezisterim in improving neurocognitive and fatigue-related symptoms, reflecting governmental support for this research initiative.
- Market Performance and Outlook: Despite BioVie’s current trading price of $1.46, down 3.95%, the upcoming topline results from the Phase 2 SUNRISE-PD trial are expected to generate optimism in the market, particularly regarding potential breakthroughs in Parkinson's disease treatment.
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Analyst Views on BIVI
About BIVI
BioVie Inc. is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company's drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-kB, and the associated neuroinflammation and insulin resistance, but not ERK and NFkB homeostatic functions (such as insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of Alzheimer’s disease (AD) and Parkinson’s disease (PD). Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of long COVID. In liver disease, the Company's orphan drug candidate BIV201, is being evaluated for Phase III clinical testing for the reduction of further decompensation in participants with liver cirrhosis and ascites.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BioVie Completes Enrollment in Bezisterim Trial for Long COVID
- Trial Enrollment Completed: BioVie Inc. announced the completion of enrollment in its Phase 2 ADDRESS-LC trial for Bezisterim, targeting the neurological symptoms of Long COVID affecting approximately 15 million people in the U.S., indicating significant progress in addressing this unmet medical need.
- Drug Mechanism and Applications: Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier to modulate key neuroinflammatory pathways, aimed at alleviating symptoms in patients with Long COVID, Alzheimer's, and Parkinson's disease, showcasing its broad clinical application potential.
- Trial Design and Funding: The trial is a randomized, placebo-controlled, multicenter study fully funded by the U.S. Department of War, primarily assessing the safety and efficacy of Bezisterim in improving neurocognitive and fatigue-related symptoms, reflecting governmental support for this research initiative.
- Market Performance and Outlook: Despite BioVie’s current trading price of $1.46, down 3.95%, the upcoming topline results from the Phase 2 SUNRISE-PD trial are expected to generate optimism in the market, particularly regarding potential breakthroughs in Parkinson's disease treatment.
See More
BioVie Hosts KOL Event to Discuss New Drug Mechanism
- KOL Event Announcement: BioVie will host a virtual KOL event on May 7, 2026, featuring Dr. Suzanne de la Monte from Brown University, aimed at discussing the mechanism of action of bezisterim and its implications for understanding neurodegenerative diseases, particularly Parkinson's disease.
- Clinical Trial Progress: BioVie’s Phase 2 trial indicates that Parkinson's patients receiving bezisterim in conjunction with levodopa exhibited improved motor control and reported fewer morning symptoms, highlighting the drug's potential to enhance patient quality of life.
- Long COVID Research: The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's effects on lingering neurological symptoms associated with Long COVID, with preliminary hypotheses suggesting these symptoms may be linked to persistent inflammation, with topline data expected in mid-2026.
- Alzheimer's Disease Studies: BioVie has completed both Phase 2 and Phase 3 trials for Alzheimer's disease, with preliminary data suggesting improvements in cognition and biomarkers, supporting further clinical trials to assess its therapeutic potential for the six million Americans affected by the disease.
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- Biotech Advancements: BioVie Inc. is advancing a clinical trial for Parkinson's disease with 60 patients enrolled, expecting topline data in May 2026, which could significantly bolster its market position in the biopharmaceutical sector if successful.
- Obstructive Sleep Apnea Solutions: Vivos Therapeutics Inc.'s FDA-cleared non-surgical oral appliance aims to provide a long-term solution for the estimated one billion people affected by OSA globally, with strategic growth initiatives targeting direct-to-patient markets.
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Halper Sadeh LLC Investigates BioVie Executives' Fiduciary Duties
- Legal Investigation Launched: Halper Sadeh LLC is investigating whether certain officers and directors of BioVie Inc. breached their fiduciary duties to shareholders, potentially leading to governance reforms.
- Shareholder Rights Protection: Long-term shareholders of BioVie may seek corporate governance reforms, fund returns, or court-approved financial incentive awards, enhancing their rights and interests.
- Transparency Improvement: Shareholder involvement can improve the company's policies, practices, and oversight mechanisms, promoting more transparent and effective management, thereby increasing shareholder value.
- Legal Fee Arrangement: Halper Sadeh LLC will handle the case on a contingent fee basis, meaning shareholders will not be responsible for out-of-pocket legal fees or expenses, reducing the financial burden of participation.
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BioVie Inc. Investigated for Potential Breach of Fiduciary Duties by Executives
- Shareholder Rights Investigation: Halper Sadeh LLC is investigating whether executives of BioVie Inc. breached their fiduciary duties, which could impact corporate governance and shareholder rights.
- Legal Relief Options: Long-term shareholders of BioVie may seek corporate governance reforms, fund recovery, or court-approved financial incentives, aimed at enhancing company transparency and accountability.
- Importance of Participation: Shareholder involvement can improve company policies and oversight mechanisms, thereby enhancing shareholder value and increasing the effectiveness of corporate management.
- Legal Fee Arrangement: Halper Sadeh LLC will handle the case on a contingency fee basis, meaning shareholders will not incur out-of-pocket legal fees, reducing the financial burden of participation.
See More
BioVie Completes Enrollment in Bezisterim Trial for Long COVID
- Trial Enrollment Completed: BioVie Inc. announced the completion of enrollment in its Phase 2 ADDRESS-LC trial for Bezisterim, targeting the neurological symptoms of Long COVID affecting approximately 15 million people in the U.S., indicating significant progress in addressing this unmet medical need.
- Drug Mechanism and Applications: Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier to modulate key neuroinflammatory pathways, aimed at alleviating symptoms in patients with Long COVID, Alzheimer's, and Parkinson's disease, showcasing its broad clinical application potential.
- Trial Design and Funding: The trial is a randomized, placebo-controlled, multicenter study fully funded by the U.S. Department of War, primarily assessing the safety and efficacy of Bezisterim in improving neurocognitive and fatigue-related symptoms, reflecting governmental support for this research initiative.
- Market Performance and Outlook: Despite BioVie’s current trading price of $1.46, down 3.95%, the upcoming topline results from the Phase 2 SUNRISE-PD trial are expected to generate optimism in the market, particularly regarding potential breakthroughs in Parkinson's disease treatment.
See More
BioVie Hosts KOL Event to Discuss New Drug Mechanism
- KOL Event Announcement: BioVie will host a virtual KOL event on May 7, 2026, featuring Dr. Suzanne de la Monte from Brown University, aimed at discussing the mechanism of action of bezisterim and its implications for understanding neurodegenerative diseases, particularly Parkinson's disease.
- Clinical Trial Progress: BioVie’s Phase 2 trial indicates that Parkinson's patients receiving bezisterim in conjunction with levodopa exhibited improved motor control and reported fewer morning symptoms, highlighting the drug's potential to enhance patient quality of life.
- Long COVID Research: The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's effects on lingering neurological symptoms associated with Long COVID, with preliminary hypotheses suggesting these symptoms may be linked to persistent inflammation, with topline data expected in mid-2026.
- Alzheimer's Disease Studies: BioVie has completed both Phase 2 and Phase 3 trials for Alzheimer's disease, with preliminary data suggesting improvements in cognition and biomarkers, supporting further clinical trials to assess its therapeutic potential for the six million Americans affected by the disease.
See More
New Show to Air Tonight on Bloomberg Television
- Global Broadcast Expansion: New to The Street's latest episode will air tonight at 6:30 PM EST on Bloomberg Television, extending its reach to the U.S., MENA, and Latin America, thereby enhancing international investor engagement and broadening its audience base.
- Biotech Advancements: BioVie Inc. is advancing a clinical trial for Parkinson's disease with 60 patients enrolled, expecting topline data in May 2026, which could significantly bolster its market position in the biopharmaceutical sector if successful.
- Obstructive Sleep Apnea Solutions: Vivos Therapeutics Inc.'s FDA-cleared non-surgical oral appliance aims to provide a long-term solution for the estimated one billion people affected by OSA globally, with strategic growth initiatives targeting direct-to-patient markets.
- Virtual Reality Market Growth: Virtuix Holdings Inc.'s Omni One platform has reported a 138% year-over-year growth in the gaming and fitness sectors, with production capacity supporting potential annual revenues of up to $100 million, indicating strong demand in both consumer and defense markets.
See More
Halper Sadeh LLC Investigates BioVie Executives' Fiduciary Duties
- Legal Investigation Launched: Halper Sadeh LLC is investigating whether certain officers and directors of BioVie Inc. breached their fiduciary duties to shareholders, potentially leading to governance reforms.
- Shareholder Rights Protection: Long-term shareholders of BioVie may seek corporate governance reforms, fund returns, or court-approved financial incentive awards, enhancing their rights and interests.
- Transparency Improvement: Shareholder involvement can improve the company's policies, practices, and oversight mechanisms, promoting more transparent and effective management, thereby increasing shareholder value.
- Legal Fee Arrangement: Halper Sadeh LLC will handle the case on a contingent fee basis, meaning shareholders will not be responsible for out-of-pocket legal fees or expenses, reducing the financial burden of participation.
See More
New to The Street Broadcasts Show #716 Featuring SDST and Others
- Broadcast Timing: New to The Street will air Show #716 tonight at 6:30 PM Eastern Time on Bloomberg Television, enhancing its influence in the business media landscape by showcasing various public companies.
- Company Highlights: The episode will spotlight Stardust Power Inc. (NASDAQ:SDST), BioVie Inc. (NASDAQ:BIVI), and Roadzen Inc. (NASDAQ:RDZN), showcasing innovations in critical minerals, biotechnology, and AI-driven mobility and insurance solutions, aimed at attracting investor interest.
- Celebrity Features: The show will also include special segments with Kelsey Grammer discussing his new book KAREN and Andrew Shaw introducing his nonprofit 250DAYS.ORG, emphasizing the importance of mental health awareness and recovery, thereby enhancing the program's social impact.
- International Expansion Plans: New to The Street plans to launch its international version in the MENA region on January 24, 2026, further expanding its global reach, while also preparing to launch the Spanish-language platform Nuevo En La Calle, showcasing its diversified media strategy.
See More
BioVie Inc. Investigated for Potential Breach of Fiduciary Duties by Executives
- Shareholder Rights Investigation: Halper Sadeh LLC is investigating whether executives of BioVie Inc. breached their fiduciary duties, which could impact corporate governance and shareholder rights.
- Legal Relief Options: Long-term shareholders of BioVie may seek corporate governance reforms, fund recovery, or court-approved financial incentives, aimed at enhancing company transparency and accountability.
- Importance of Participation: Shareholder involvement can improve company policies and oversight mechanisms, thereby enhancing shareholder value and increasing the effectiveness of corporate management.
- Legal Fee Arrangement: Halper Sadeh LLC will handle the case on a contingency fee basis, meaning shareholders will not incur out-of-pocket legal fees, reducing the financial burden of participation.
See More
