---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-108360"
form_type: "8-K"
ticker: "ANVS"
cik: "0001477845"
company_name: "Annovis Bio, Inc."
filed_at: "2024-10-15T23:59:59+00:00"
generated_at: "2026-05-30T14:31:37.353495+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA Clears Annovis to Start Pivotal Phase 3 Alzheimer's Studies for Buntanetap

## Summary
- FDA clearance to proceed with pivotal Phase 3 studies for buntanetap in early Alzheimer's disease.
- Two trials: a 6-month symptomatic study and an 18-month disease-modifying study.
- A well-executed 6-month trial may support NDA filing within one year of initiation.
- No safety concerns raised; FDA confirmed liver enzymes, drug interactions, dose selection acceptable.
- CEO Maria Maccecchini says trial initiation planned early 2025.

## SEC filing metadata
- accession: 0001104659-24-108360
- form_type: 8-K
- ticker: ANVS
- cik: 0001477845
- company_name: Annovis Bio, Inc.
- filed_at: 2024-10-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1477845/000110465924108360/0001104659-24-108360-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1477845/000110465924108360/tm2426152d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-108360
- JSON: https://secwatch.observer/filing/0001104659-24-108360.json
- Plain text: https://secwatch.observer/filing/0001104659-24-108360.txt

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