secwatch.observer — SEC 8-K summary
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Issuer:     BIOVIE INC. (BIVI)
CIK:        0001580149
Form:       8-K
Filed at:   2022-12-07T23:59:59+00:00
Accession:  0001520138-22-000553
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioVie reports positive NE3107 data in Parkinson's, Alzheimer's, and aging biomarkers
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- NE3107+levodopa improved UPDRS Part 3 by 3+ points vs levodopa alone at 2-3 hours (clinically meaningful); 6+ points for patients <70.
- NE3107 improved cognition: ADAS-Cog12 +2.2 points (p=0.0173), CDR +0.11 (p=0.0416), ADCOMS +0.07 (p=0.0094) in mild cognitive impairment/mild AD.
- NE3107 reduced Horvath DNA methylation SkinBlood clock by 3.3 years (p=0.0021) after 3 months; 19 of 22 patients showed reduction.
- BioVie increased Phase 3 AD trial enrollment from 316 to 400; topline results expected before end of Q3 2023.
- Company plans to discuss Phase 3 Parkinson's program with FDA and expects to launch Phase 3 trials in 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1580149/000152013822000553/0001520138-22-000553-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1580149/000152013822000553/bivi-20221207_8k.htm
  HTML page:      https://secwatch.observer/filing/0001520138-22-000553

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer