Setback for CytoDyn as US FDA returns leronlimab submission

14 July 2020

Washington, USA-based biotech CytoDyn (OTCMKTS: CYDY) has received a Refusal to File letter for leronlimab, causing shares in the company to fall more than a fifth.

The firm, which is developing the CCR5 antagonist for multiple therapeutic indications including in oncology and immunology, submitted to the US regulator for approval in HIV.

The firm’s Biologics License Application (BLA) described a combination therapy, with HAART, for highly treatment-experienced people with HIV.

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