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 its management team's participation in the LifeSci Partners 11th Annual Corporate Access Event, scheduled for January 5-7, 2022. The panel, titled "Defining Yourself When You Fit Into More Than One Basket," will take place on January 7, 2022, at 10:00 AM ET.
BioVie is focused on developing innovative therapies for advanced liver disease and neurodegenerative disorders. Its key candidates include BIV201 for liver cirrhosis and NE3107 for Alzheimer's, with ongoing trials aimed at addressing significant unmet medical needs.
BioVie Inc. (NASDAQ: BIVI) is launching a campaign with the American Liver Foundation to enhance awareness about liver cirrhosis and its complications, specifically refractory ascites. This initiative coincides with BioVie’s Phase 2b clinical trial of BIV201, a continuous infusion of terlipressin, aimed at treating this condition. Approximately 20,000 Americans suffer from refractory ascites, with a one-year survival rate of only 50%. The trial is being conducted at ten research centers in the U.S., and positive results could lead to a pivotal Phase 3 study commencing in 2022.
BioVie Inc. (NASDAQ: BIVI) announced a new debt facility with Avenue Venture Funds, providing up to $25 million, with an initial funding of $15 million on November 30, 2021. This funding aims to support key clinical milestones in 2022, including top-line data from trials of BIV201 in refractory ascites and NE3107 in Alzheimer’s. The company anticipates initiating a Phase 2 trial of NE3107 for Parkinson's disease and a Phase 3 trial for BIV201 for hepatorenal syndrome-acute kidney injury. This non-dilutive financing positions BioVie to advance innovative therapies for unmet medical needs.
BioVie Inc. (NASDAQ: BIVI) announced a key opinion leader webinar on November 11, 2021, focusing on liver cirrhosis complications and an update on the Phase 2b BIV201 study. The session features experts Michael Porayko and Paolo Angeli, who will discuss the progression of liver cirrhosis and the use of terlipressin for hepatorenal syndrome. BIV201, aimed at treating refractory ascites due to liver cirrhosis, holds Orphan drug and Fast Track designations. Top-line results from the Phase 2 study are expected in mid-2022, with a Phase 3 study planned for HRS-AKI pending FDA authorization.
BioVie Inc. has appointed Dr. Joseph M. Palumbo as its new Chief Medical Officer. Dr. Palumbo, a veteran in the pharma industry, will oversee the development of therapies for neurodegenerative and liver diseases. He will lead clinical programs such as NE3107, targeting Alzheimer's and Parkinson's diseases, and BIV201, aimed at treating complications of liver cirrhosis. His extensive experience in drug development is expected to enhance BioVie’s clinical operations, improving the potential for successful trials.
BioVie (NASDAQ: BIVI) has received FDA authorization to commence a Phase 2 study evaluating NE3107 for its potential pro-motoric effects in Parkinson's disease patients. This double-blind, placebo-controlled trial will involve 40 participants and assess safety, tolerability, and efficacy through established motor ratings. NE3107 demonstrates promise in reducing neuroinflammation and enhancing insulin sensitivity, critical to neurodegenerative diseases. The company anticipates patient enrollment to begin by late 2021 and topline results by mid-2022.
BioVie Inc. (NASDAQ: BIVI) has announced a webinar on October 26, 2021, addressing neuroinflammation and insulin resistance related to Alzheimer's Disease. Key opinion leaders will discuss the inflammatory mechanisms in Alzheimer's, while BioVie management will outline the clinical progress of NE3107, their treatment candidate targeting Alzheimer's. The NM101 Phase III clinical study for NE3107 has begun, with 316 subjects enrolled for this randomized trial aimed at treating mild to moderate Alzheimer's. This initiative marks a significant step in BioVie’s plans for addressing neurodegenerative disorders.
BioVie Inc. (NASDAQ: BIVI) announced its management team's participation at the Cantor Virtual Global Healthcare Conference from September 27-30, 2021. A presentation is scheduled for September 29, 2021, at 11:20 a.m. EST, with a webcast available for investors. BioVie, focused on innovative therapies for neurological and liver diseases, is also progressing its Phase 2 study for its Orphan drug candidate BIV201 and initiating a Phase 3 study for NE3107 in Alzheimer's disease. More details can be found on their website.
BioVie Inc. (NASDAQ: BIVI) announced its management team's participation in the Oppenheimer Fall Healthcare Life Sciences & MedTech Virtual Summit on September 22, 2021, at 12:25 p.m. EST. This conference will provide an update on BioVie’s innovative drug therapies targeting neurodegenerative disorders and advanced liver disease. BioVie is currently evaluating BIV201 for refractory ascites and plans to initiate a Phase 3 study for hepatorenal syndrome. Additionally, the company is conducting a pivotal study for NE3107, aimed at treating Alzheimer's disease, with results expected in late 2022.
BioVie Inc. (NASDAQ: BIVI) has successfully closed its underwritten public offering, raising $20 million through the sale of 2.5 million shares of Class A common stock at $8.00 each. The offering includes an option for underwriters to purchase an additional 375,000 shares for overallotments. Proceeds will primarily support general corporate purposes. BioVie is advancing drug therapies for neurological disorders, liver diseases, and certain cancers, with notable candidates like BIV201 for liver disease and NE3107 targeting Alzheimer's.
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