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 Inc. (NASDAQ: BIVI) has secured all scientific approvals needed to receive an additional $12.6 million in grant funding from the U.S. Department of Defense for a planned Phase 2 trial of bezisterim in long COVID. The U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO) approved BioVie's plan to evaluate bezisterim for treating neurological symptoms associated with long COVID. This approval follows the FDA's Safe to Proceed designation in August 2024.
The Phase 2 study, expected to commence by early 2025, will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety, tolerability, and potential efficacy of bezisterim in reducing neurocognitive symptoms of long COVID over a 3-month treatment period. Bezisterim, which can cross the blood-brain barrier, targets inflammation via NF-kB activation, addressing a suspected underlying cause of long COVID symptoms.
BioVie Inc. (NASDAQ: BIVI) has received FDA authorization for its Investigational New Drug (IND) application to evaluate bezisterim in a Phase 2 trial for treating neurological symptoms associated with long COVID. This milestone puts BioVie on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense and initiate the trial. The planned study will be a randomized, placebo-controlled, multicenter trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over a 3-month treatment period.
Long COVID affects about 5.5% of U.S. adults, with approximately 3.6 million people reporting significant activity modifications due to the illness. Bezisterim's potential to modulate inflammation by activating NF-kB and its ability to permeate the blood-brain barrier make it a promising candidate for addressing the underlying mechanisms of long COVID symptoms.
BioVie Inc. (NASDAQ: BIVI) presented clinical data on bezisterim at the 11th Aging Research and Drug Discovery Meeting, revealing its potential to modulate inflammation and the biological aging process. Key findings include:
1. Patients treated with bezisterim experienced a 2-4 year age deceleration advantage compared to placebo.
2. Bezisterim modulated DNA methylation of proinflammatory genes and appeared to promote the transition of M1 proinflammatory to M2 anti-inflammatory macrophages.
3. The drug was associated with a 1.5 to 2.3 'fold enrichment' on gene control for hundreds of genes in pathways linked to neurodegenerative disorders and biological processes.
These results suggest bezisterim's potential to impact various age-related diseases and inflammation-related conditions.
BioVie Inc. (NASDAQ: BIVI) announced a poster presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) in Copenhagen, Denmark. The presentation, titled 'Bezisterim Effects on Biological Age, Alzheimer's Epigenetics, and Neurologic Assessments', will showcase clinical data on bezisterim, focusing on its potential impact on longevity and the biological aging process.
Christopher L. Reading, BioVie's Senior VP of Alzheimer's Disease Program, will deliver the presentation on August 27, 2024. The company aims to highlight bezisterim's effects on biological age, gene expression, and measures of aging-related diseases. Detailed data and conclusions will be announced after the public presentation at the conference.
BioVie Inc. (NASDAQ: BIVI) has announced alignment with the FDA for its SUNRISE-PD trial to evaluate bezisterim (NE3107) in Parkinson's disease. The trial will assess the drug's effect on motor and non-motor symptoms in approximately 60 patients naive to carbidopa/levodopa. The FDA recommended including the MDS-UPDRS Part II score as a primary endpoint, which is already part of the trial design as a secondary endpoint. BioVie plans to initiate patient screening in Q4 2024. This Phase 2 study aims to explore bezisterim's impact on newly diagnosed patients, complementing earlier trials and potentially establishing its applicability for the entire Parkinson's patient population.
BioVie Inc. (NASDAQ: BIVI) has announced the implementation of a 1-for-10 reverse stock split of its issued and outstanding Class A common stock, effective August 6, 2024. The company's shares began trading on a split-adjusted basis on the same day, maintaining its listing on The Nasdaq Capital Market under the symbol "BIVI". This action follows the approval by BioVie stockholders at a Special Meeting held on July 29, 2024. The reverse split aims to adjust the company's share structure, potentially impacting its market capitalization and share price. Investors can find detailed information about the Special Meeting in the company's definitive proxy statement filed with the SEC on June 17, 2024, available on the SEC website and BioVie's corporate website.
BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.
Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).
BioVie presented the upcoming SUNRISE-PD Phase 2 trial design at ATMRD 2024, evaluating bezisterim (NE3107) on motor and non-motor symptoms in early Parkinson's disease patients. The trial will involve 60 participants, randomized to receive either bezisterim or placebo for 12 weeks. Key objectives include assessing motor symptom improvements, non-motor symptoms, and overall PD symptoms. In parallel, they presented Phase 2a data showing bezisterim's potential as an adjunctive therapy to carbidopa/levodopa, with significant improvements in motor functions and non-motor symptoms like sleep and restlessness. These findings support further evaluation in a larger trial. If successful, participants may join a future long-term safety study.
BioVie and Mobilicom will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV, airing June 22 at 7 p.m. ET. BioVie's CEO, Cuong Do, discusses the company's late-stage clinical programs targeting neurodegeneration and liver disease, highlighting their lead asset, bezisterim, which has shown promising results in clinical trials for Parkinson's and Alzheimer's diseases. Key milestones include a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.
Mobilicom's CEO, Oren Elkayam, will talk about their investment opportunities. Mobilicom's products, like SkyHopper Datalinks and the ICE Cybersecurity Suite, have led to significant market penetration, with 50 customers in 18 countries. The company achieved 43% revenue growth and a 59% gross margin in 2023, ending the year with $8.4 million in cash, indicating a solid financial position to execute their strategic plans.
BioVie announced two poster presentations at the ATMRD Congress in Washington, D.C., from June 21-25, 2024. The presentations will focus on the Phase 2 trial protocol for bezisterim (NE3107) in early Parkinson’s patients and its impact on motor and non-motor symptoms, specifically for those not yet treated with carbidopa/levodopa. The first poster will be displayed on June 22 from 5-5:30 p.m. EDT, outlining the study protocol. Another poster will be shown the same day from 4:20-4:50 p.m. EDT, featuring data on bezisterim’s effects when used alongside carbidopa/levodopa.
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