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. (BIVI) is a clinical-stage biotechnology company pioneering novel therapies for chronic liver disease complications and neurodegenerative disorders. This page serves as the definitive source for all official company updates, including clinical trial progress, regulatory milestones, and strategic developments.
Access real-time announcements about BIV201 for liver ascites management and bezisterim for Alzheimer’s/Parkinson’s research. Stay informed on orphan drug designations, partnership agreements, and financial disclosures that shape BioVie’s innovative pipeline.
All content is rigorously curated to provide investors and researchers with compliant, actionable insights. Bookmark this hub for authoritative updates on therapies addressing critical unmet medical needs through advanced clinical research.
BioVie (NASDAQ: BIVI) presented promising data on bezisterim at the 7th World Aging and Rejuvenation Conference, highlighting its potential to slow biological aging and neurodegeneration. The Phase 3 NM101 study analysis revealed that bezisterim-treated Alzheimer's patients showed significant biological age reduction compared to placebo across multiple epigenetic clocks, with differences ranging from -1.38 to -4.24 years.
The study demonstrated bezisterim's ability to modulate inflammation and gene activation, with treated patients showing significant improvements in key biomarkers including -8.5 mg/dL in fasting glucose, -15 mg/dL in cholesterol, and -90.5 pg/mL in MCP. Bezisterim, a stabilized version of Beta AET, uniquely offers oral availability and blood-brain barrier penetration while maintaining favorable safety profiles in Alzheimer's and Parkinson's Disease trials.
BioVie (NASDAQ: BIVI) announced the presentation of its SUNRISE-PD Phase 2 clinical trial design at the Advanced Therapeutics in Movement & Related Disorders® Congress. The trial evaluates bezisterim (NE3107) in early-stage Parkinson's Disease patients through a hybrid, decentralized approach.
The innovative trial design allows participants aged 41-80, diagnosed within the last four years, to complete visits either at home or in clinic. The study features in-home nurse visits, neurologist oversight via video conferencing, and remote assessment of motor symptoms. BioVie has partnered with organizations including The Michael J. Fox Foundation to support enrollment.
Bezisterim is an oral, anti-inflammatory, insulin-sensitizing compound that has demonstrated improvements in both motor and non-motor symptoms in previous trials, targeting key biological processes in PD progression.
BioVie (NASDAQ: BIVI) announced it will present a poster highlighting its Phase 2 SUNRISE-PD clinical trial at the Advanced Therapeutics in Movement & Related Disorders® Congress from June 27-30, 2025. The presentation will focus on the trial's decentralized design and patient experience in evaluating bezisterim (NE3107) for early Parkinson's disease treatment.
The Phase 2b SUNRISE-PD trial is a multicenter, randomized, double-blind, placebo-controlled study with a hybrid decentralized design lasting 20 weeks. Patients can participate either from home or at clinical sites, with home visits conducted by study nurses and remote neurologist supervision. The trial includes a modified MDS-UPDRS Part III examination, with successful participants potentially eligible for a longer-term, open-label safety study.
BioVie (NASDAQ: BIVI) has initiated patient enrollment in its Phase 2 ADDRESS-LC clinical trial evaluating bezisterim (NE3107) for treating neurological symptoms of long COVID. The trial, funded by the U.S. Department of Defense, is a randomized, placebo-controlled study focusing on patients with cognitive impairment and fatigue. Topline data is expected in the first half of 2026.
Long COVID affects approximately 20 million adults in the US, with 10-30% of COVID-19 patients experiencing persistent symptoms. The study aims to address the lack of approved treatment options for long COVID patients suffering from debilitating fatigue and brain fog. Bezisterim targets key neuroinflammation mechanisms and has shown potential in reducing chronic symptoms in Alzheimer's and Parkinson's disease trials.
BioVie (NASDAQ: BIVI) announced a virtual Key Opinion Leader (KOL) event scheduled for May 28, 2025, focusing on their Phase 2 trial of bezisterim (NE3107) for Parkinson's disease treatment. The event will feature experts Dr. Suzanne de la Monte from Brown University and Dr. Mark Stacy from Medical University of South Carolina.
The discussion will center on the SUNRISE-PD trial, which is currently enrolling newly diagnosed Parkinson's patients. Bezisterim is an oral small molecule designed to reverse insulin resistance and selectively inhibit inflammation-driven processes. The study aims to evaluate the drug's impact on clinical signs and biomarkers potentially related to disease modification.
BioVie Inc. (NASDAQ: BIVI) has initiated the Phase 2 SUNRISE-PD clinical trial to evaluate bezisterim (NE3107) in early Parkinson's disease patients who haven't received carbidopa/levodopa treatment. The trial has enrolled its first patient, with topline data expected in late 2024 or early 2025.
The study is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial featuring a hybrid decentralized design lasting 20 weeks. Approximately 60 patients will be randomized 1:1 to receive either 20 mg of bezisterim or placebo twice-daily over a 12-week double-blind phase.
Key features include:
- Remote participation option through decentralized trial sites
- Support from major organizations including The Michael J. Fox Foundation
- Full funding secured in November 2024
- Focus on bezisterim's anti-inflammatory and insulin-sensitizing properties
BioVie Inc. (NASDAQ: BIVI) announced a virtual investor event scheduled for April 10, 2025, at 10:00 AM ET, featuring Key Opinion Leader Dr. Lindsay McAlpine from Yale University. The webcast will focus on the long COVID treatment landscape and provide updates on BioVie's ADDRESS-LC trial.
The trial evaluates bezisterim (NE3107), a novel oral anti-inflammatory and insulin-sensitizing agent that can cross the blood-brain barrier. The drug selectively inhibits inflammation-driven ERK- and NF-κB-stimulated inflammatory mediators while preserving their homeostatic functions. The discussion will address how chronic neuroinflammation, potentially caused by persisting viral spike protein, may explain long COVID symptoms persistence.
BioVie (NASDAQ: BIVI) announced the acceptance of an abstract detailing their planned Phase 2 trial of bezisterim for Long COVID treatment at the Demystifying Long COVID International Conference in Barcelona. The study, fully funded by the U.S. Department of Defense, will be a double-blind, randomized, placebo-controlled trial involving approximately 200 patients. The trial aims to evaluate the safety, tolerability, and potential efficacy of bezisterim over a 3-month treatment period, focusing on reducing neurocognitive symptoms associated with Long COVID. The presentation will be delivered on November 21, 2024.
BioVie (NASDAQ: BIVI) has secured full funding for its upcoming PD-202 Parkinson's Disease clinical trial through recent secondary offerings raising over $15 million. The double-blind, randomized, placebo-controlled study of bezisterim in early Parkinson's Disease patients is scheduled to begin in early 2025, with topline results expected by late 2025. The company's lead asset, bezisterim, has shown promising results in clinical studies, demonstrating reduced inflammation, improved motor function, and decreased non-motor symptoms in PD patients. BioVie's strategic plans include launching Phase 2 trials for PD and Long Covid in early 2025, followed by a Phase 3 trial for Alzheimer's Disease in late 2025.
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