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

CytoDyn Inc.

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.

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.