CYDY - CytoDyn voluntarily withdrawing BLA for HIV treatment leronlimab

• CytoDyn ( OTCQB:CYDY ) has voluntarily withdrawn a pending Biologics License Application for its HIV biologic leronlimab due to issues related to data collection and trial monitoring by its contract research organization .
• The company noted that it does not believe it can win approval of the candidate in the HIV multi-drug resistant population "without significant additional investment to remedy the issues."
• CytoDyn said it plans to soon publish in a peer-reviewed journal data from a phase 2b/3 randomized, placebo-controlled trial that met the primary endpoint.
• It added that it will continue examining leronlimab for other HIV indications, non-alcoholic steatohepatitis ( NASH ), and oncology indications.
• The company added it believes its current data is sufficient to submit responses to the US FDA to remove a clinical hold on its HIV program.
• The hold was placed in late March .

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