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 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.
BioVie Inc. (NASDAQ: BIVI) announced promising preliminary results from its Phase 2 Alzheimer’s trial for NE3107, reporting an 82% response rate with a mean cognitive improvement of -2.6 points on the ADAS-Cog12 scale. The Phase 3 trial has enrolled over half of the targeted patients and is expected to read out mid-2023. Early data from a Phase 2 Parkinson’s trial is also encouraging, with upcoming data readouts anticipated across various trials within the next 12 months.
BioVie Inc. (NASDAQ: BIVI) announced participation in Cantor Fitzgerald’s Neurology & Psychiatry Conference on October 6-7, 2022, in San Francisco. The management team will be involved in a panel discussion titled Wave of innovation for Alzheimer’s disease on October 7 at 12:00 PM ET. The company is advancing drug therapies targeting Alzheimer’s and Parkinson’s diseases through its lead candidate NE3107. Additionally, BioVie's BIV201 is in a Phase 2 study for liver disease, with anticipated top-line results due in mid-2023.
BioVie Inc. (NASDAQ: BIVI) is set to feature in an interview on The RedChip Money Report, airing on Bloomberg TV on September 17, discussing advancements in clinical research. CEO Cuong Do will outline the promising top-line results from a Phase 2 study of NE3107 for Alzheimer's Disease, along with updates on ongoing Phase 3 and Phase 2 trials related to Alzheimer's and Parkinson's diseases, respectively. The company is focusing on addressing unmet medical needs in chronic liver and neurodegenerative disorders, with significant milestones expected soon.
BioVie (NASDAQ: BIVI) has released significant updates from its Phase 2 clinical trial regarding NE3107 for Alzheimer’s Disease (AD). The trial demonstrated that a vast majority of patients experienced notable improvements in daily abilities and cognition, with 82% of participants showing a decrease in ADAS-Cog12 scores (p=0.0046). Moreover, NE3107 treatment correlated with reductions in TNF-a, suggesting potential neuroinflammation benefits. No adverse events were reported, and the company plans to present detailed results at the upcoming CTAD 2022 Annual Conference.
BioVie Inc. (NASDAQ: BIVI) announced the issuance of a U.S. patent for terlipressin monotherapy to treat ascites patients without hepatorenal syndrome, restoring patent protection for BIV201 until 2036. This patent, along with global applications and Orphan drug designation, aims to secure long-term intellectual property. Currently, there are no FDA-approved drugs for ascites treatment, affecting approximately 20,000 U.S. patients annually. The company is conducting a Phase 2b trial to evaluate BIV201's efficacy, with results expected in early 2023.
BioVie Inc. (NASDAQ: BIVI) announced its management team's participation in the virtual B. Riley Securities’ Neuro & Ophthalmology Conference on April 27-28, 2022. CEO Cuong Do and CMO Joseph Palumbo will discuss the novel mechanism of action of NE3107, BioVie’s lead compound targeting Alzheimer’s and Parkinson’s diseases. The fireside chat is scheduled for April 28, 2022, at 1:30 PM ET. Additionally, BioVie is advancing its drug candidate BIV201 for liver disease, with anticipated Phase 2 study results expected in early 2023.
BioVie Inc. (NASDAQ: BIVI) will feature an interview with President and CEO Cuong Do on The RedChip Money Report® airing March 12 at 7 p.m. ET on Bloomberg TV, reaching approximately 73 million households. BioVie is focused on developing therapies for advanced liver disease and neurodegenerative disorders. The company's key candidates include BIV201, which is currently in a US Phase 2 study for refractory ascites, and NE3107, undergoing a Phase 3 trial for mild to moderate Alzheimer's disease, with results expected in early 2023.
BioVie, a clinical-stage company listed on NASDAQ under the stock symbol BIVI, announced its participation in the Oppenheimer Virtual Annual Healthcare Conference from March 15-17, 2022. The presentation is scheduled for March 17 at 12:40 PM ET. BioVie is focused on innovative therapies for advanced liver disease and neurodegenerative disorders. Its candidate BIV201 is in a Phase 2 study targeting refractory ascites due to liver cirrhosis, with results expected in mid-2022. Additionally, NE3107 is in trials for Alzheimer’s and Parkinson’s diseases, aiming for primary completion in early 2023.
BioVie Inc. (NASDAQ: BIVI) has initiated the treatment of its first patient in a Phase 2 clinical trial (NM201) investigating the effects of NE3107 on Parkinson’s disease. This double-blind placebo-controlled study aims to evaluate safety, tolerability, and pharmacokinetics in 40 patients. NE3107 previously demonstrated promising effects in preclinical studies, improving motor symptoms and reducing L-dopa induced dyskinesia. Results are expected by mid-2022, with the trial being a significant milestone for the company's development pipeline in neurodegenerative diseases.
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