CytoDyn Stock Falls After FDA Rebukes Claims On COVID-19 Treatment

The FDA has accused CytoDyn Inc CYDY of trying to pick and choose data from two failed studies of leronlimab in COVID-19 patients to claim the drug is effective.
In March, the Phase 3 trial of CytoDyn’s leronlimab failed on the primary goal of reducing symptoms and all secondary goals, including one that questioned whether the therapy could reduce mortality.
But the company instead focused its data release on a subgroup of 62 mechanically ventilated, critically ill COVID-19 patients, claiming that the drug spurred a 24% reduction in all-cause mortality and a six-day decrease in hospitalization.
“It has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19,” the FDA said. “None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.”
“With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.”
“The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).”
Price Action: CYDY shares are down 4.41% at $1.95 during the premarket session on the last check Tuesday.

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