---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-019804"
form_type: "8-K"
ticker: "CYDY"
cik: "0001175680"
company_name: "CytoDyn Inc."
filed_at: "2023-12-14T23:59:59+00:00"
generated_at: "2026-06-07T12:32:35.656845+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# CytoDyn: FDA lifts partial clinical hold, imposes new full hold on revised protocol; expects January 2024 submission

## Summary
- Partial clinical hold from March 2022 lifted by FDA in December 2023.
- New full clinical hold placed on proposed HIV trial protocol submitted November 2023.
- Company to incorporate FDA feedback and submit amended protocol by January 2024.
- Views partial hold resolution as significant step; full hold expected resolved after response.
- Proposed HIV study aims to establish leronlimab's mechanism of action cost-effectively.

## SEC filing metadata
- accession: 0001558370-23-019804
- form_type: 8-K
- ticker: CYDY
- cik: 0001175680
- company_name: CytoDyn Inc.
- filed_at: 2023-12-14T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175680/000155837023019804/0001558370-23-019804-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175680/000155837023019804/cydy-20231214x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-019804
- JSON: https://secwatch.observer/filing/0001558370-23-019804.json
- Plain text: https://secwatch.observer/filing/0001558370-23-019804.txt

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