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. (OTC Pink: BIVI) is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies for chronic and debilitating conditions. The company's primary areas of research include chronic liver diseases, neurological disorders, and certain cancers.
BioVie's lead drug candidate, BIV201, targets ascites, a severe complication associated with advanced liver cirrhosis caused by hepatitis, non-alcoholic steatohepatitis (NASH), or alcoholism. Ascites affects approximately 100,000 Americans and has a high mortality rate of around 40% within two years of diagnosis. BIV201, based on the drug terlipressin, is currently entering a Phase 2 clinical trial in the US. Terlipressin is already approved in about 40 countries for treating liver cirrhosis complications, highlighting the potential of BIV201 to address a significant unmet medical need in the US. Notably, the FDA has not yet approved any drug specifically for ascites, and BIV201 has obtained orphan drug status.
Besides its liver disease program, BioVie is also advancing its NE3107 candidate, aimed at treating neurological and neuro-degenerative disorders. The company is conducting a Phase 3 randomized, double-blind, placebo-controlled study to evaluate NE3107 in patients with mild to moderate Alzheimer's disease. Additionally, NE3107 has shown promise in improving both motor and non-motor symptoms in Parkinson's disease, with significant improvements observed in patient trials.
BioVie has secured strategic investments from prominent investors, including Aspire Capital, Cuong Do (Global Strategy Lead for Samsung), and Hari Kumar (Founder of Adheron Therapeutics). These partnerships underscore the confidence in BioVie's innovative drug development pipeline.
Recent studies and presentations have highlighted the potential of NE3107 in addressing Alzheimer's and Parkinson's diseases. For instance, NE3107-treated patients exhibited improvements in cognitive and functional measures, biological age deceleration, and metabolic inflammation-driven systems dysregulation. These findings suggest that NE3107 could significantly impact core symptoms of these conditions by modulating inflammation and enhancing insulin sensitivity in the brain.
BioVie remains committed to advancing its clinical programs and delivering novel therapies to improve the lives of patients suffering from these challenging conditions.
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.
BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, announced CEO Cuong Do's participation at the B. Riley Securities’ Neuroscience Conference on April 28, 2021, at 3:00 PM ET. He will present BioVie’s acquisition plans for NeurMedix's assets, focusing on Alzheimer's and Parkinson's treatments. Additionally, a KOL Discussion will feature leading experts on neuroinflammation in Alzheimer's on April 29. BioVie is advancing drug candidate NE3107, targeting Alzheimer’s, and BIV201 for ascites treatment, with clinical trials underway.
BioVie Inc. (NASDAQ: BIVI) announced the acquisition of NeurMedix's biopharmaceutical assets, including its lead drug candidate NE3107, aimed at treating neurodegenerative diseases. The deal involves $3 million in cash, over $7 million contingent on clinical success, and 8.36 million shares. This acquisition expands BioVie’s pipeline into critical areas like Alzheimer’s and Parkinson’s Disease. Cuong V. Do has been appointed CEO to lead this transition, bringing extensive industry experience. The pivotal Phase 3 trial for NE3107 is scheduled to begin mid-2021.
BioVie Inc. (NASDAQ: BIVI) announced its participation in the 31st Annual Oppenheimer Healthcare Conference, with a presentation scheduled for March 18, 2021, at 8:40 AM ET. CEO Terren Peizer and COO Jonathan Adams will discuss the company’s lead candidate, BIV201, a treatment for ascites due to advanced liver cirrhosis. BIV201 is an Orphan drug candidate, with plans to initiate a second Phase 2 clinical trial in early 2021. BioVie has secured FDA clearance for a novel injection delivery system for BIV201, enhancing patient compliance and simplifying administration.
BioVie Inc. (NASDAQ: BIVI) has initiated patient screening for its Phase 2 Trial of BIV201, a continuous infusion of terlipressin, targeting refractory ascites, a serious liver disease complication. The trial is set to evaluate BIV201's efficacy alongside standard-of-care in patients, with primary endpoints including the incidence of severe complications and changes in cumulative ascites over 12 weeks. With no FDA-approved treatments for ascites, the study aims to address a critical unmet medical need, potentially leading to significant market opportunities.
BioVie Inc. (NASDAQ: BIVI) announced that CEO Terren Peizer will be interviewed on The RedChip Money Report® airing February 20. The discussion focuses on BIV201, an orphan drug candidate targeting ascites from advanced liver cirrhosis and its market potential. The company is preparing for patient enrollment in its upcoming Phase 2 clinical trial and highlights its novel delivery system for BIV201. The FDA has granted Orphan Drug designation and Fast Track status for BIV201, enhancing its commercial prospects.
FAQ
What is the current stock price of BioVie (BIVI)?
What is the market cap of BioVie (BIVI)?
What does BioVie Inc. specialize in?
What is BIV201?
What is NE3107?
Why is BIV201 significant?
Who are some of BioVie's strategic investors?
What recent achievements has BioVie made?
What are the primary focus areas of BioVie's research?
How does NE3107 work?
What is the market potential for BIV201?
How can investors and media inquire about BioVie?
