secwatch.observer — SEC 8-K summary
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Issuer:     BIOVIE INC. (BIVI)
CIK:        0001580149
Form:       8-K
Filed at:   2023-10-25T23:59:59+00:00
Accession:  0001520138-23-000457
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioVie presents blinded Phase 3 NE3107 data at CTAD; cognitive, biomarker improvements observed
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- Blinded data (n=322) show statistically significant population changes from baseline on ADAS-Cog12, ADCS-CGIC, MMSE, CDR, CDR-SB, ADCOMS, ADL.
- Apparent reduction in amyloid burden: 36.5% of PrecivityAD-positive patients reverted to negative after 30 weeks.
- Significant increases in insulin and beta cell function (HOMA2-%B +13.5%, p<0.0001) without hypoglycemia.
- FDG-PET SUVRs increased in 10 of 21 sub-study patients, suggesting reduced amyloid burden.
- Company expects unblinded topline data in late November or early December 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1580149/000152013823000457/0001520138-23-000457-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1580149/000152013823000457/bivi-20231025_8k.htm
  HTML page:      https://secwatch.observer/filing/0001520138-23-000457

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