Shares of CytoDyn Inc. were up 0.5% in trading on Tuesday, the day after the Food and Drug Administration issued a statement saying “it has become clear” that the clinical-trial data supplied by the company for its experimental COVID-19 treatment does not “support the clinical benefit of leronlimab.” The drug candidate, leronlimab, is a monoclonal antibody being tested in several trials as a treatment for hospitalized COVID-19 patients or those individuals with mild-to-moderate disease. The regulator does not normally make statements like this, that aim to explain the nuances of how a company conducts its clinical trials and gathers data about investigational therapies. “If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company,” the FDA said. CytoDyn plans to hold an investor call on Tuesday at 4 p.m. ET in response to the FDA statement. CytoDyn’s stock is down 62.3% this year, while the S&P 500 is up 10.8%.
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