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 (NASDAQ: BIVI) has announced encouraging preliminary results from its Phase 2 trial of NE3107 for Parkinson's Disease (PD). Six out of 20 patients treated with NE3107 experienced a morning 'on state', compared to none in the placebo group (p=0.02). This state is crucial for PD patients as it indicates optimal motor function. Additionally, NE3107-treated patients showed a significant improvement in motor scores on the Unified Parkinson's Disease Rating Scale compared to those on levodopa alone. The company plans to initiate Phase 3 trials for NE3107, following favorable Phase 2 results.
BioVie Inc. (NASDAQ: BIVI) announced the successful completion of patient enrollment for its NM101 trial, evaluating NE3107 in Alzheimer’s patients, achieving a revised target of 400 patients. The trial is a pivotal Phase 3 study aimed at assessing cognition and function in mild to moderate Alzheimer’s disease patients. Top line results are anticipated in October 2023. The study protocol adapted to increased interest, allowing for enhanced statistical power. Previous Phase 2 results indicated improved cognition with NE3107 treatment. The company aims to address neuroinflammation and insulin resistance related to neurodegenerative diseases.
BioVie (NASDAQ: BIVI) has announced its upcoming BioVie Day on March 23, 2023, at 10 a.m. EST, where it will present a comprehensive overview of recent clinical trial data on its treatments for Alzheimer's, Parkinson's, and liver diseases. This event aims to summarize progress, discuss new clinical trials, and outline plans for regulatory submissions. Notable achievements include the promising Phase 2 results for NE3107 in Alzheimer's and Parkinson's, showing significant cognitive and motor control improvements. Additionally, the liver disease candidate BIV201 holds FDA Fast Track status. More details will be shared as the date approaches.
BioVie Inc. (NASDAQ: BIVI) will be featured in an interview on The RedChip Money Report on Bloomberg TV on December 31, 2022, at 7 p.m. ET. CEO Cuong Do will discuss positive Phase 2 clinical trial data for Alzheimer's and Parkinson's diseases, and plans for potential FDA approval in 2024. BioVie is developing innovative therapies for neurodegenerative disorders and liver disease, with key studies underway for its drug candidates NE3107 and BIV201. The interview will be accessible online and aims to inform investors about the company’s progress.
BioVie Inc. (NASDAQ: BIVI) recently reported significant advancements with its drug candidate NE3107 for treating Parkinson's disease (PD) and Alzheimer's disease (AD). In a trial, PD patients using NE3107 experienced a meaningful increase in motor control after 28 days. Additional data indicated that NE3107 improved cognition in mild cognitive impairment and mild AD patients. Notably, NE3107 reduced biomarkers of aging-related disease by approximately 3.3 years after 3 months of treatment. The company is moving toward Phase 3 trials based on promising results.
BioVie Inc. (NASDAQ: BIVI), a clinical-stage company, announced positive findings from its Phase 2 trial for NE3107, aimed at improving cognitive functions in Alzheimer's patients. The study revealed NE3107 may reduce Horvath DNA methylation SkinBlood clock by 3.3 years after 3 months of treatment. Among 23 patients, results indicated significant cognitive enhancement, with 2.2 point improvement on the modified ADAS-Cog12 scale and a reduction in CSF phospho-tau levels. No adverse events were reported, suggesting NE3107's potential in addressing aging-related diseases.
BioVie Inc. (BIVI) announced positive results from two Phase 2 trials evaluating NE3107 for Parkinson's and Alzheimer's diseases. In the Parkinson's trial, patients receiving NE3107 with levodopa achieved a clinically meaningful improvement of over 3 points in motor function compared to levodopa alone. Notably, those under 70 saw a 6-point enhancement. In the Alzheimer's trial, NE3107 improved cognition, showing a 2.1-point gain on the ADAS-Cog12 scale. Additionally, biomarkers related to neuroinflammation decreased without any adverse effects reported.
BioVie Inc. (BIVI) has increased the enrollment target for its Phase 3 trial evaluating NE3107 in Alzheimer’s patients from 316 to 400 due to rapid recruitment and favorable safety data. Over 316 patients are already enrolled, and the company anticipates completing enrollment in two months, with topline results expected by 3Q2023. The trial aims to assess cognition and functional improvement in patients with mild to moderate Alzheimer's disease. The decision to expand enrollment is based on positive early findings and the absence of serious adverse events.
BioVie Inc. (NASDAQ: BIVI) announced that three abstracts from its Phase 2 study of NE3107 for Alzheimer's Disease were accepted for presentation at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, scheduled for November 29-December 2, 2022, in San Francisco, CA.
The presentations include:
- Oral: Neuroimaging Data on December 2 at 11:15am PT
- Posters: Biomarker Assessments on December 1 and Clinical Outcomes on November 29-30.
Results will be disclosed post-conference.
BioVie Inc. (NASDAQ: BIVI), a clinical-stage company, announced its abstract on the hospitalization burden of cirrhosis and ascites at The Liver Meeting 2022 to be held in Washington, DC from November 4-6, 2022. The poster presentation, titled U.S. Hospitalization Burden of Patients with Cirrhosis and Ascites Receiving Paracentesis, is scheduled for November 6, 2022, from 1:00-2:00pm. BioVie develops innovative therapies targeting neurological disorders and advanced liver disease. Notable products include NE3107 for Alzheimer’s and Parkinson’s diseases and BIV201 for treating refractory ascites.
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