CYDY - CytoDyn plunges as FDA rebukes its clinical trials for COVID-19 therapy

CytoDyn ([[CYDY]] -26.4%) is trading sharply lower after the FDA issued a critical review of the company’s clinical trials designed to evaluate the experimental COVID-19 therapy leronlimab in COVID-19.The regulator highlights the importance of a well-designed clinical trial to assess the safety and efficacy of a medicine in particular clinical use.“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 FDA said in a statement.For CD12 trial, none of the analyses “has met statistical significance when using established and reliable analytical methods,” when adjusted for multiple comparisons, the federal agency says adding that such evaluations could inform the design of future trial for leronlimab in COVID-19.“If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA

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CytoDyn plunges as FDA rebukes its clinical trials for COVID-19 therapy