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. (NASDAQ: BIVI) generates news primarily through its clinical development programs in neurological and neurodegenerative disorders and advanced liver disease. Company announcements frequently highlight progress with its lead candidate bezisterim (NE3107) in Alzheimer’s disease, Parkinson’s disease and long COVID, as well as developments in its BIV201 program for complications of advanced liver cirrhosis.
Recent news releases have described milestones in the SUNRISE-PD Phase 2 trial in early Parkinson’s disease, including the use of a hybrid, decentralized design that allows participants to complete visits at home or in clinics, and the completion of enrollment in that study. BioVie also issues updates on scientific presentations at international conferences, where it has discussed bezisterim’s potential effects on biological aging markers, DNA methylation patterns, inflammatory gene expression, and metabolic and inflammatory biomarkers in Alzheimer’s disease.
In long COVID, BioVie’s news flow includes coverage of the ADDRESS-LC Phase 2 trial, which is enrolling adults with fatigue and cognitive impairment associated with long COVID and is fully funded by a U.S. Department of Defense grant. Press releases describe the trial’s enrichment strategy, objective cognitive endpoints, and the rationale for targeting neuroinflammation and insulin resistance in this condition.
BioVie also reports on capital markets and corporate events, such as underwritten public offerings of units consisting of common stock (or pre-funded warrants) and warrants, the listing of its warrants under the symbol BIVIW, and investor webinars featuring management discussing clinical data and program updates. Regulatory and governance news, including reverse stock split implementation, proxy statements, and board appointments, is disclosed through SEC filings and related communications.
Investors and observers following BIVI news can expect updates on clinical trial enrollment and topline data timing, scientific presentations, financing transactions, and corporate governance actions, all of which are documented in the company’s press releases and regulatory filings.
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.
BioVie Inc. (NASDAQ: BIVI) has announced the full enrollment of 44 patients in its Phase 2 trial assessing the effects of NE3107 on Parkinson's disease, with topline data expected in December 2022. The double-blind, placebo-controlled study focuses on both safety and efficacy, particularly analyzing NE3107's interaction with levodopa. Preliminary assessments indicate no drug-related adverse events and suggest a potential efficacy signal. NE3107 is being developed as a treatment for neurodegenerative diseases, and BioVie also has a Phase 3 Alzheimer's trial underway.