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) has priced its public offering of 2,500,000 shares of Class A common stock at $8.00 per share, generating gross proceeds of $20,000,000. The underwriters have a 45-day option to purchase an additional 375,000 shares. Proceeds will primarily be used for general corporate purposes. The offering is conducted under a shelf registration statement filed with the SEC. BioVie is developing therapies for neurological disorders and liver disease, including BIV201, which is in clinical trials aimed at addressing significant medical needs.
BioVie Inc. (NASDAQ: BIVI) announced plans for an underwritten public offering of its common stock, with all shares to be sold by the company. The offering is managed by ThinkEquity and is subject to market conditions, with no guarantee on its completion or terms. Proceeds are intended for general corporate purposes. The securities will be offered under a registration statement filed with the SEC. The company is engaged in developing therapies for chronic conditions, including a Phase 2 study of BIV201 for liver disease and a Phase 3 study of NE3107 for Alzheimer's.
BioVie Inc. (NASDAQ: BIVI) has initiated the NM101 Phase III clinical study, enrolling its first patient to test NE3107 for Alzheimer’s Disease. This pivotal study involves 316 subjects and aims to assess cognitive, functional, and behavioral endpoints, as well as brain glucose utilization. NE3107 has shown promise in previous studies for reducing neuroinflammation and insulin resistance, which are associated with cognitive decline in Alzheimer’s. The study's results are expected by the end of 2022.
BioVie is also advancing its liver disease treatment, BIV201, and plans to evaluate NE3107 in Parkinson’s Disease.
BioVie Inc. announced its pivotal Phase 3 trial of NE3107, an anti-inflammatory insulin sensitizer for Alzheimer’s Disease. The trial, named NM101, involves 316 subjects and aims to assess various cognitive and glycemic endpoints. Previous studies showcased NE3107's efficacy in reducing neuroinflammation and insulin resistance, critical to Alzheimer’s pathology. The trial is set to complete data analysis by late 2022. Furthermore, BioVie is developing another drug, BIV201, for liver disease, with results expected in early 2022. NE3107 and related compounds are patented first-in-class molecules.
BioVie to Present Phase 3 Alzheimer's Trial at AAIC
BioVie Inc. announced its participation in the 2021 Alzheimer’s Association International Conference (AAIC) from July 26-30, where it will present its Phase 3 trial NM101 for NE3107, aiming to treat mild to moderate Alzheimer's disease. The trial is a randomized, placebo-controlled study involving 316 subjects, assessing cognitive functions and glycemic control. The trial's primary completion is expected by late 2022, marking a significant advancement in anti-inflammatory therapies for Alzheimer’s.
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.
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