CYDY - CytoDyn submits dose justification report to FDA for leronlimab BLA in HIV

CytoDyn (CYDY) has submitted a dose justification report to the FDA, which will be followed by an official submission to CytoDyn’s IND.The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab for HIV patients.Following FDA feedback, CytoDyn will begin submission of BLA modules by specified timelines in accordance with FDA guidance and approval. “We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology," commented Chris Recknor, M.D., CytoDyn’s Chief Operating Officer and Head of Clinical Development.The company is on track for the top line report for the COVID-19 long-haulers symptoms/biomarker trial and will soon start two COVID-19 trials in Brazil.Recently, the company announces preliminary results from its COVID-19 long-haulers clinical trial.

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CytoDyn submits dose justification report to FDA for leronlimab BLA in HIV