Biovie Inc Stock Price, News & Analysis

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.

BioVie Inc. (NASDAQ: BIVI) announces amendments to the acquisition of NeurMedix, Inc., focusing on therapeutic assets for neurodegenerative disorders. The upfront payment remains at 8,361,308 shares and $3 million in cash. Key changes include a cap on contingent stock payments at 18 million shares down from $3 billion. Additional cash payments of $7.3 million hinge on clinical trial milestones. The deal is projected to close by June 2021, with a Phase 3 trial for Alzheimer’s expected to start shortly.

BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, announced CEO Cuong Do's participation at the B. Riley Securities’ Neuroscience Conference on April 28, 2021, at 3:00 PM ET. He will present BioVie’s acquisition plans for NeurMedix's assets, focusing on Alzheimer's and Parkinson's treatments. Additionally, a KOL Discussion will feature leading experts on neuroinflammation in Alzheimer's on April 29. BioVie is advancing drug candidate NE3107, targeting Alzheimer’s, and BIV201 for ascites treatment, with clinical trials underway.

BioVie Inc. (NASDAQ: BIVI) announced the acquisition of NeurMedix's biopharmaceutical assets, including its lead drug candidate NE3107, aimed at treating neurodegenerative diseases. The deal involves $3 million in cash, over $7 million contingent on clinical success, and 8.36 million shares. This acquisition expands BioVie’s pipeline into critical areas like Alzheimer’s and Parkinson’s Disease. Cuong V. Do has been appointed CEO to lead this transition, bringing extensive industry experience. The pivotal Phase 3 trial for NE3107 is scheduled to begin mid-2021.

BioVie Inc. (NASDAQ: BIVI) announced its participation in the 31st Annual Oppenheimer Healthcare Conference, with a presentation scheduled for March 18, 2021, at 8:40 AM ET. CEO Terren Peizer and COO Jonathan Adams will discuss the company’s lead candidate, BIV201, a treatment for ascites due to advanced liver cirrhosis. BIV201 is an Orphan drug candidate, with plans to initiate a second Phase 2 clinical trial in early 2021. BioVie has secured FDA clearance for a novel injection delivery system for BIV201, enhancing patient compliance and simplifying administration.