After trading sideways for most of the time in Monday’s trading session, CytoDyn Inc (OTCMKTS:CYDY) saw a steep rise in the final hour of trading after the FDA issued a critical review.
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.
In the 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 trials for leronlimab in COVID-19.
CYDY stock slumped over 27% to end the session at $2.04. The stock has lost 80% from its 52-week high of $10.01.
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Anthony Gonzales brings 3 years of experience in helping grassroots, mid-sized organizations and large institutions strengthen their management and resource generating capacities and effectively plan for the future. He is also a mentor and professional advisor to artists working in all disciplines. He is the gold medalist from St. Marco University of Science and Technology in the Bachelors of Financial Management as well.