The U.S FDA (Food and Drug Administration) has provided CytoDyn with guidance on its recent HIV BLA dose justification report, a crucial part of the company’s resubmission for its Biologics License Application (BLA) for HIV. CytoDyn is known for specializing in late-stage biotechnology and for developing leronlimab, a new personalized monoclonal antibody specialized in targeting the CCR5 receptor. CytoDyn has successfully completed its Phase 3 trial to study the combined treatment of leronlimab and standard antiretroviral therapies in patients infected with HIV. In addition, CytoDyn is in the process of conducting a few clinical trials in Phase 2, one of which studies patients with post-acute sequelae of SARS COV-2, also known as COVID-19 long haulers.

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