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) announced the acceptance of an abstract detailing their planned Phase 2 trial of bezisterim for Long COVID treatment at the Demystifying Long COVID International Conference in Barcelona. The study, fully funded by the U.S. Department of Defense, will be a double-blind, randomized, placebo-controlled trial involving approximately 200 patients. The trial aims to evaluate the safety, tolerability, and potential efficacy of bezisterim over a 3-month treatment period, focusing on reducing neurocognitive symptoms associated with Long COVID. The presentation will be delivered on November 21, 2024.
BioVie (NASDAQ: BIVI) has secured full funding for its upcoming PD-202 Parkinson's Disease clinical trial through recent secondary offerings raising over $15 million. The double-blind, randomized, placebo-controlled study of bezisterim in early Parkinson's Disease patients is scheduled to begin in early 2025, with topline results expected by late 2025. The company's lead asset, bezisterim, has shown promising results in clinical studies, demonstrating reduced inflammation, improved motor function, and decreased non-motor symptoms in PD patients. BioVie's strategic plans include launching Phase 2 trials for PD and Long Covid in early 2025, followed by a Phase 3 trial for Alzheimer's Disease in late 2025.
BioVie Inc (Nasdaq: BIVI) has completed its previously announced registered direct offering of 1,146,000 shares of common stock at $2.83 per share, raising gross proceeds of $3,243,180. The clinical-stage company, which develops drug therapies for liver disease and neurological disorders, plans to use the net proceeds for working capital and general corporate purposes. ThinkEquity served as the sole placement agent for the offering, which was conducted under a shelf registration statement filed with the SEC in August 2023.
BioVie Inc. (NASDAQ: BIVI) has announced the pricing of a registered direct offering of 1,146,000 shares of common stock at $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds. The offering, priced at-the-market under Nasdaq rules, is expected to close around October 29, 2024. ThinkEquity is serving as the sole placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The securities are being offered through a shelf registration statement previously filed with the SEC.
BioVie Inc (NASDAQ: BIVI) announced the pricing of a registered direct offering of 1,146,000 shares of common stock at $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds. The offering, priced at-the-market under Nasdaq rules, is expected to close around October 29, 2024. The company plans to use the net proceeds for working capital and general corporate purposes. ThinkEquity is serving as the sole placement agent for the offering, which is being conducted under a shelf registration statement previously filed with the SEC.
BioVie Inc (Nasdaq: BIVI) has completed its previously announced registered direct offering of 2,667,000 shares of common stock at $2.25 per share. The company also conducted a concurrent private placement of unregistered warrants to purchase up to 2,667,000 shares at $2.12 per share. The warrants will be exercisable after six months and expire five years after the initial exercise date. The offering generated gross proceeds of $6,000,750, which will be used for working capital and general corporate purposes. ThinkEquity served as the sole placement agent for the offering.
BioVie Inc (NASDAQ: BIVI) announced the pricing of a registered direct offering of 2,667,000 shares of common stock at $2.25 per share, raising gross proceeds of $6,000,750. The company will also issue unregistered warrants to purchase up to 2,667,000 shares in a concurrent private placement, with an exercise price of $2.12 per share. The warrants will be exercisable after six months and expire five years after the initial exercise date. The proceeds will be used for working capital and general corporate purposes. ThinkEquity is serving as the sole placement agent, with the offering expected to close around October 24, 2024.
BioVie Inc. (Nasdaq: BIVI) has announced the closing of its previously announced registered direct offering and concurrent private placement. The company sold 4,443,000 shares of common stock at $1.50 per share in a registered direct offering. Additionally, in a private placement, BioVie issued unregistered warrants to purchase up to 4,443,000 shares of common stock at an exercise price of $1.37 per share.
The gross proceeds from the offering amount to $6,664,500. BioVie intends to use the net proceeds primarily for working capital and general corporate purposes. ThinkEquity acted as the sole placement agent for the offering. The common stock was offered through a shelf registration statement, while the warrants were issued in a private placement under exemptions from registration.
BioVie Inc. (NASDAQ: BIVI) has announced the pricing of a registered direct offering of 4,443,000 shares of common stock at $1.50 per share, raising gross proceeds of $6,664,500. The company is also issuing unregistered warrants to purchase up to 4,443,000 shares in a concurrent private placement. These warrants have an exercise price of $1.37 per share, will be exercisable after six months, and expire five years from the initial exercise date.
The offering is expected to close around October 22, 2024. BioVie plans to use the net proceeds for working capital and general corporate purposes. ThinkEquity is acting as the sole placement agent for this offering, which is being conducted under a shelf registration statement filed with the SEC.
BioVie Inc. (NASDAQ: BIVI) has received a Notice of Allowance from the Japan Patent Office for its novel liquid formulation of terlipressin acetate. This formulation, which is stable at room temperature for up to 24 months, can be packaged in a pre-filled syringe, offering significant advantages for treating patients with cirrhosis and ascites, particularly in home-care settings.
The company has now secured patents for this formulation in the United States, India, Japan, and Chile, with pending applications in eight additional markets. This development strengthens BioVie's intellectual property protection and enhances the value of its BIV201 program, which aims to provide a more patient-centric ambulatory treatment for ascites and hepatic failure.
Terlipressin is currently used in over 40 countries to treat complications of liver cirrhosis, but the recent US approval is for a lyophilized powder form requiring reconstitution and refrigeration. BioVie's liquid formulation offers improved convenience and safety, potentially benefiting patients with cirrhosis and ascites, who currently face treatment options and poor survival rates.
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