CYDY - CytoDyn receives positive response from FDA for Phase 3 leronlimab study in COVID-19

CytoDyn (OTCQB:CYDY) has received a positive response from the FDA to conduct a Phase 3, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation. Patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered via IV infusion weekly over a four-week treatment period (dosage on days 0, 7, 14, and 21). CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis.

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CytoDyn receives positive response from FDA for Phase 3 leronlimab study in COVID-19