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

BIOVIE INC.

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.