secwatch.observer — SEC 8-K summary
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Issuer:     CytoDyn Inc. (CYDY)
CIK:        0001175680
Form:       8-K
Filed at:   2022-10-28T23:59:59+00:00
Accession:  0001558370-22-015602
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175680/000155837022015602/0001558370-22-015602-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175680/000155837022015602/cydy-20221028x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-015602

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