CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been
…More working diligently to refile its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the filing.