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BioVie (BIVI) Stock News, Sep-Dec 2022

BIVI NASDAQ

BioVie, Inc. develops clinical-stage drug therapies for neurological and neurodegenerative diseases and advanced liver disease. Company news centers on bezisterim, also known as NE3107, an investigational oral small molecule studied in Parkinson’s disease, Alzheimer’s disease and Long COVID through its effects on neuroinflammation and insulin sensitivity.

Recurring updates include clinical-study enrollment and results planning, scientific-conference abstracts, key opinion leader events and investor presentations. BioVie also reports on BIV201, its orphan drug candidate for refractory ascites associated with liver cirrhosis, alongside corporate communications about pipeline progress and financing activity.

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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.

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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.

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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.

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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.

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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.

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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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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of BioVie (BIVI)?

BioVie (BIVI) last closed at $1.33.

What is the market cap of BioVie (BIVI)?

The market cap of BioVie (BIVI) is approximately $12.8M.