CYDY - CytoDyn files for rolling review of leronlimab in COVID-19 in U.S. U.K. and Canada

CytoDyn (CYDY) announces multiple regulatory pathways for approval of leronlimab for critical COVID-19 in the U.S., U.K. and Canada. MHRA will accept more data from the open-label portion of Company's current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.Also, CytoDyn has initiated the process to submit an Interim Order ((IO)) with Health Canada for the sale of leronlimab. The U.S. FDA has received CYDY's protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint of length of hospital stay. An “age adjustment” analysis was performed and the updated results are as follows: Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to ones who received “commonly used COVID-19 treatments” alone in the placebo group. Statistically significant results

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CytoDyn files for rolling review of leronlimab in COVID-19 in U.S., U.K. and Canada