BioVie, Inc. develops clinical-stage drug therapies for neurological and neurodegenerative diseases and advanced liver disease. Company news centers on bezisterim, also known as NE3107, an investigational oral small molecule studied in Parkinson’s disease, Alzheimer’s disease and Long COVID through its effects on neuroinflammation and insulin sensitivity.
Recurring updates include clinical-study enrollment and results planning, scientific-conference abstracts, key opinion leader events and investor presentations. BioVie also reports on BIV201, its orphan drug candidate for refractory ascites associated with liver cirrhosis, alongside corporate communications about pipeline progress and financing activity.
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.
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.