---
schema_version: "secwatch.filing_event.v1"
accession: "0001520138-23-000511"
form_type: "8-K"
ticker: "BIVI"
cik: "0001580149"
company_name: "BIOVIE INC."
filed_at: "2023-11-29T23:59:59+00:00"
generated_at: "2026-06-07T20:17:28.014652+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BioVie Phase 3 NE3107 Alzheimer's trial misses primary endpoint; positive per-protocol trends

## Summary
- Primary endpoint missed statistical significance due to exclusion of patients from 15 sites with GCP violations; sites referred to FDA.
- Per-protocol analysis (57 patients) showed NE3107 cognitive and functional improvement vs placebo comparable to approved monoclonal antibodies.
- NE3107-treated patients had 4.66-year age deceleration advantage vs placebo via Horvath DNA methylation clock.
- Company plans to work with FDA on adaptive design to continue enrolling patients toward statistical significance.

## SEC filing metadata
- accession: 0001520138-23-000511
- form_type: 8-K
- ticker: BIVI
- cik: 0001580149
- company_name: BIOVIE INC.
- filed_at: 2023-11-29T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1580149/000152013823000511/0001520138-23-000511-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1580149/000152013823000511/bivi-20231129_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001520138-23-000511
- JSON: https://secwatch.observer/filing/0001520138-23-000511.json
- Plain text: https://secwatch.observer/filing/0001520138-23-000511.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.