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. (NASDAQ: BIVI) generates news primarily through its clinical development programs in neurological and neurodegenerative disorders and advanced liver disease. Company announcements frequently highlight progress with its lead candidate bezisterim (NE3107) in Alzheimer’s disease, Parkinson’s disease and long COVID, as well as developments in its BIV201 program for complications of advanced liver cirrhosis.
Recent news releases have described milestones in the SUNRISE-PD Phase 2 trial in early Parkinson’s disease, including the use of a hybrid, decentralized design that allows participants to complete visits at home or in clinics, and the completion of enrollment in that study. BioVie also issues updates on scientific presentations at international conferences, where it has discussed bezisterim’s potential effects on biological aging markers, DNA methylation patterns, inflammatory gene expression, and metabolic and inflammatory biomarkers in Alzheimer’s disease.
In long COVID, BioVie’s news flow includes coverage of the ADDRESS-LC Phase 2 trial, which is enrolling adults with fatigue and cognitive impairment associated with long COVID and is fully funded by a U.S. Department of Defense grant. Press releases describe the trial’s enrichment strategy, objective cognitive endpoints, and the rationale for targeting neuroinflammation and insulin resistance in this condition.
BioVie also reports on capital markets and corporate events, such as underwritten public offerings of units consisting of common stock (or pre-funded warrants) and warrants, the listing of its warrants under the symbol BIVIW, and investor webinars featuring management discussing clinical data and program updates. Regulatory and governance news, including reverse stock split implementation, proxy statements, and board appointments, is disclosed through SEC filings and related communications.
Investors and observers following BIVI news can expect updates on clinical trial enrollment and topline data timing, scientific presentations, financing transactions, and corporate governance actions, all of which are documented in the company’s press releases and regulatory filings.
BioVie Inc. has announced the upcoming pivotal Phase 3 trial of its drug candidate NE3107 for treating Alzheimer’s disease, expected to start in summer 2021. The trial aims to evaluate NE3107's effectiveness in slowing cognitive decline and is based on a published article detailing its scientific rationale. NE3107 has shown a favorable safety profile and potential for neuroinflammation and insulin resistance inhibition. This trial will involve approximately thirty clinical sites in the U.S. and is pivotal in addressing significant unmet medical needs in Alzheimer’s care.
BioVie Inc. announces that its drug candidate NE3107 will be featured in the American Diabetes Association's Thought Leadership Film Series. NE3107 is an ERK inhibitor targeting neuroinflammation and insulin resistance, pivotal for Alzheimer’s and Parkinson’s diseases. The company plans a Phase 3 trial to evaluate NE3107's efficacy in slowing cognitive decline in Alzheimer’s patients. BioVie also has a Phase 2 study underway for its liver disease treatment BIV201, with results expected in early 2022.
BioVie Inc. (NASDAQ: BIVI) announced its inclusion in the Russell Microcap Index, effective June 28, 2021. This membership is expected to enhance liquidity and broaden the shareholder base for the company. With the acquisition of NeurMedix's biopharma assets now complete, BioVie is poised for growth. The company is developing innovative therapies for liver diseases and neuro-degenerative disorders, including the FDA Fast Track-designated BIV201, aimed at treating refractory ascites and hepatorenal syndrome. NE3107, another asset targeting neuroinflammation, has been authorized for a pivotal Phase 3 trial.
BioVie Inc. discusses its late-stage drug pipeline in an interview featuring Chairman Terren Peizer, set to air on The RedChip Money Report on June 26, 2021. The company focuses on innovative therapies for liver disease, neurological disorders, and certain cancers. Major highlights include BIV201, which is under investigation for refractory ascites and hepatorenal syndrome, and NE3107, aimed at reducing neuroinflammation and insulin resistance in Alzheimer’s and Parkinson’s diseases. The Phase 3 study for NE3107 is planned for mid-2021.
BioVie Inc. (NASDAQ: BIVI) announced the enrollment of its first patient in the Phase 2b trial of BIV201, aimed at treating refractory ascites. This condition lacks FDA-approved therapies, presenting a significant unmet medical need. The trial, involving 30 subjects across nine sites, aims to establish the efficacy of BIV201 compared to standard care. With an estimated 20,000 Americans suffering from refractory ascites and a dire one-year survival rate of about 50%, the trial's progress is critical. Top-line results are expected in early 2022, with plans for a pivotal Phase 3 trial if successful.
BioVie Inc. (NASDAQ: BIVI) announced plans for a potentially pivotal Phase 3 study of BIV201, targeting hepatorenal syndrome-acute kidney injury (HRS-AKI), following positive FDA feedback. HRS-AKI, linked to advanced liver cirrhosis, has a high mortality rate if untreated. BioVie aims to file a New Drug Application based on trial results. Additionally, the company is conducting a Phase 2b study of BIV201 for ascites due to liver cirrhosis. The FDA has also approved a Phase 3 study for NE3107, focusing on Alzheimer’s disease.
BioVie Inc. (NASDAQ: BIVI) announced an upcoming interview with CEO Cuong Do, set to air on The RedChip Money Report® on June 19, 2021. The interview will cover key milestones in the company’s programs, including a pivotal Phase 3 trial for Alzheimer's involving NE3107 and a Phase 2 study of BIV201 for refractory ascites. BioVie is developing therapies for liver disease and neurological disorders, with BIV201 currently under FDA Fast Track status. Top-line results for BIV201 are anticipated in early 2022.
BioVie Inc. (NASDAQ: BIVI) has successfully closed its acquisition of NeurMedix, a clinical-stage pharmaceutical company, enhancing its pipeline in neurodegenerative diseases. The primary asset acquired is NE3107, a first-in-class small molecule that targets inflammatory ERK signaling, potentially offering a novel treatment for Alzheimer’s and Parkinson’s diseases, which affect millions in the U.S. The FDA has authorized a pivotal Phase 3 trial for NE3107, marking a significant step for BioVie in addressing unmet medical needs in these severe conditions.
BioVie Inc. (NASDAQ: BIVI) announced a research and development day on May 19, 2021, featuring discussions on its lead pipeline assets: NE3107 and BIV201. NE3107 is a first-in-class treatment for Alzheimer's and Parkinson's diseases and is set for a pivotal Phase 3 study this summer. BioVie plans to acquire NE3107 from NeurMedix, with the transaction expected to close in June. BIV201, an Orphan drug candidate for ascites treatment, is in a Phase 2b study and has received FDA designations for expedited review.
BioVie Inc. (NASDAQ: BIVI) announces amendments to the acquisition of NeurMedix, Inc., focusing on therapeutic assets for neurodegenerative disorders. The upfront payment remains at 8,361,308 shares and $3 million in cash. Key changes include a cap on contingent stock payments at 18 million shares down from $3 billion. Additional cash payments of $7.3 million hinge on clinical trial milestones. The deal is projected to close by June 2021, with a Phase 3 trial for Alzheimer’s expected to start shortly.
FAQ
What is the current stock price of Biovie (BIVI)?
What is the market cap of Biovie (BIVI)?
