---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-015602"
form_type: "8-K"
ticker: "CYDY"
cik: "0001175680"
company_name: "CytoDyn Inc."
filed_at: "2022-10-28T23:59:59+00:00"
generated_at: "2026-06-22T22:25:00.301388+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CytoDyn withdraws BLA for leronlimab in HIV-MDR citing CRO data issues

## Summary
- Voluntarily withdrew pending BLA for leronlimab as HIV combination therapy; FDA approval deemed not feasible due to CRO data quality issues.
- Filed claim against former CRO for breach of Master Services Agreement, seeking damages and attorney fees.
- Met primary endpoint in Phase 2b/3 HIV-MDR trial; plans to publish data in peer-reviewed journal.
- Will submit responses to FDA to lift clinical hold on HIV program and pursue other indications (NASH, oncology).
- Company retains Fast Track designation for metastatic triple-negative breast cancer with leronlimab.

## SEC filing metadata
- accession: 0001558370-22-015602
- form_type: 8-K
- ticker: CYDY
- cik: 0001175680
- company_name: CytoDyn Inc.
- filed_at: 2022-10-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1175680/000155837022015602/0001558370-22-015602-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1175680/000155837022015602/cydy-20221028x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-015602
- JSON: https://secwatch.observer/filing/0001558370-22-015602.json
- Plain text: https://secwatch.observer/filing/0001558370-22-015602.txt

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