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 is a clinical-stage biopharmaceutical company developing novel therapies for chronic liver disease and neurodegenerative disorders. The company's news flow primarily focuses on clinical trial updates, regulatory interactions, and scientific presentations related to its two main drug candidates.
The BIV201 program for liver disease generates news around clinical trial progress, regulatory milestone achievements, and patent developments. Updates typically cover trial design discussions with regulatory authorities, patient enrollment progress, and data readouts from ongoing studies evaluating the drug's potential to reduce ascites in cirrhotic patients. Announcements may also address manufacturing developments and formulation optimization efforts.
The bezisterim neurodegenerative disease program produces news related to multiple clinical trials across different indications. Updates frequently include data presentations at major medical conferences, results from completed trial phases, and announcements of new trial initiations. Conference presentations often showcase detailed analyses of cognitive assessments, motor function evaluations, and biomarker data from Alzheimer's and Parkinson's disease studies.
Corporate news includes announcements of strategic partnerships, intellectual property developments, and financing activities that support clinical development programs. The company periodically provides pipeline updates outlining development priorities and timelines for upcoming clinical milestones. Scientific publications in peer-reviewed journals may also generate news coverage when research findings are formally published.
Regulatory news encompasses communications regarding clinical trial design approvals, regulatory designation grants, and interactions with health authorities. These announcements often signal important validation of development approaches and may impact development timelines and regulatory pathways. Patent issuances and intellectual property developments also generate newsworthy announcements that strengthen the company's competitive position.
Investor-focused news includes financial results, corporate presentations, and guidance on upcoming data catalysts. The company participates in healthcare investor conferences and may announce key opinion leader webinars that provide deeper insights into disease areas and drug mechanisms of action.
BioVie (NASDAQ: BIVI) completed enrollment of 60 patients in its Phase 2 SUNRISE-PD trial testing bezisterim (NE3107) in early Parkinson’s disease patients not previously treated with carbidopa/levodopa. SUNRISE-PD uses a hybrid, decentralized design to improve access and flexibility for participants ages 41–80 diagnosed within the past four years. BioVie expects to analyze data and report topline results in 1H 2026. The company noted prior PD studies of bezisterim with levodopa/carbidopa showed symptom improvements and a favorable safety profile.
BioVie (NASDAQ: BIVI) invites investors to a live webinar on December 9, 2025 at 4:15 p.m. ET, hosted by RedChip Companies.
CEO Cuong Do will discuss bezisterim (NE3107) — an oral small molecule studied for inflammation and insulin resistance linked to Alzheimer’s, Parkinson’s, and Long COVID — and progress on BIV201, a late‑stage orphan candidate for refractory ascites. A live Q&A will follow; registration is free at the event link and questions can be pre‑submitted to BIVI@redchip.com.
BioVie (NASDAQ: BIVI), a clinical-stage biotech company, will host an investor webinar on October 8, 2025, at 4:15 p.m. ET. CEO Cuong Do will present updates on two key drug candidates: bezisterim (NE3107), targeting Alzheimer's, Parkinson's, and long COVID, and BIV201 for refractory ascites in liver cirrhosis.
The presentation will highlight bezisterim's role in addressing inflammation and insulin resistance, with clinical studies showing promising results in cognition and motor function improvement. BIV201, their late-stage orphan drug candidate, targets a condition with no current FDA-approved therapies. The company will discuss ongoing clinical programs and potential partnership opportunities.
BioVie (NASDAQ: BIVI) presented the design of its Phase 2 ADDRESS-LC trial for bezisterim at the Keystone Symposia on Long COVID. The trial, fully funded by the U.S. Department of Defense, is evaluating bezisterim for treating cognitive impairment and fatigue in Long COVID patients.
The study features a 16-week, double-blind, randomized, placebo-controlled design with a novel enrichment strategy. Bezisterim, an anti-inflammatory agent that crosses the blood-brain barrier, has shown favorable safety profiles in Alzheimer's and Parkinson's disease trials.
The trial addresses a significant medical need, as Long COVID affects an estimated 400 million people worldwide, including 18 million in the United States. The study stratifies participants by symptom duration and age, using a specialized Cogstate Cognitive Battery to assess neurocognitive improvements.
BioVie (NASDAQ: BIVI), a clinical-stage company focused on liver disease and neurological disorder therapies, has completed a $12 million public offering. The offering consisted of 6,000,000 units priced at $2.00 per unit, with each unit containing one common stock share and one warrant.
The warrants (NASDAQ: BIVIW) are immediately exercisable at $2.50 per share with a five-year expiration. The underwriter exercised a partial over-allotment option for an additional 667,300 warrants. The company plans to use the proceeds for working capital and general corporate purposes.
BioVie Inc. (NASDAQ: BIVI), a clinical-stage company focused on developing therapies for liver disease and neurological disorders, has announced the pricing of a $12 million public offering. The offering consists of 6,000,000 units priced at $2.00 per unit, with each unit comprising one share of common stock and one warrant.
The warrants (BIVIW) will be tradable on Nasdaq starting August 8, 2025, with a $2.50 exercise price and 5-year expiration. ThinkEquity serves as the sole book-running manager, with a 45-day over-allotment option for additional securities. The offering is expected to close on August 11, 2025, with proceeds intended for working capital and general corporate purposes.
BioVie (NASDAQ: BIVI) presented promising data from their Phase 3 NM101 study of Bezisterim at the 2nd World Conference on Aging and Gerontology. The study revealed that Alzheimer's Disease patients treated with Bezisterim experienced significant age deceleration compared to placebo across multiple biological clocks.
Key findings showed age deceleration advantages including -3.16 years for SkinBloodClockAge (p=0.036), -4.12 years for PhenoAge (p=0.048), and -3.77 years for InflammAge (p=0.050). The treatment demonstrated improvements in metabolic and inflammatory biomarkers, including reductions of 8.5 mg/dL in fasting glucose and 15 mg/dL in cholesterol.
Bezisterim, a stabilized version of Beta AET, showed potential in modulating gene expression related to inflammation, aging, and Alzheimer's Disease pathophysiology, while maintaining favorable safety profiles.
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.
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