Biotechnology company CytoDyn Yahoo Inc. operates in the late stages. In addition to developing treatments for multiple therapeutic indications, Leronimab develops leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. A therapeutic monoclonal antibody, Leronlimab, is one of its products designed to address unmet medical needs in the areas of the human immunodeficiency virus (HIV), cancer, immunology, and novel Coronavirus disease (COVID-19). The company has completed a Phase 2b pivotal trial including leronlimab in combination with antiretrovirals in HIV-infected treatment-experienced patients, as well as a Phase 2b/3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. The company is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. The company was previously known as RexRay Corporation. CytoDyn Inc. was established in 2002 and is based in Vancouver, Washington.

CytoDyn is a biotechnology company developing novel treatments for multiple therapeutic indications based on leronlimab, a humanized monoclonal antibody that targets the CCR5 receptor. As a result, investors will mostly pay attention to pipeline updates on the same. CytoDyn successfully completed a phase III study on leronlimab used in combination with standard antiretroviral therapies in HIV-infected patients with treatment experience. The company received a Refusal to File letter from the FDA last month regarding its Biologic License Application (“BLA”) for leronlimab in combination with highly treated HIV patients. CytoDyn was notified by the FDA that its BLA lacks certain information required to complete a substantive review. Consequently, the FDA will not accept CytoDyn’s BLA at this time.

The FDA will be contacted by CytoDyn to discuss its request for more information. Yet, the agency does not require that any additional clinical trials be conducted, while the company will conduct additional analyses of completed trials. The results of CytoDyn’s COVID-19 phase II study for mild-to-moderate indications were recently announced. The purpose of this study was to evaluate the safety and efficacy of leronlimab, and the results of the efficacy portion of the data should be available as soon as the statistical analyses of all primary and secondary endpoints have been completed. A phase II study has also been initiated by CytoDyn to evaluate leronlimab for the treatment of non-alcoholic steatohepatitis (NASH). The study will determine if leronlimab can control liver fibrosis associated with NASH.

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