Lilly submits authorization request to FDA for antibody-based COVID-19 therapy

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Shares of Eli Lilly & Co. rallied 3.2% in premarket trading on Wednesday after the drug maker said it submitted its experimental COVID-19 monoclonal antibody treatment to the Food and Drug Administration for an emergency use authorization. An EUA is not a full approval but a type of regulatory authorization used during the pandemic to speed up the process of bringing new therapies to market. The company in September had shared clinical trial data for LY-CoV555, finding that the standalone therapy could reduce the rate of hospitalization and viral load in some mild to moderately ill COVID-19 patients. Lilly said it has the capacity to manufacture one million doses of the monotherapy in the fourth quarter of this year. It also released interim data from a randomized, double-blind, placebo-controlled Phase 2 study testing a combination of LY-CoV555 and LY-CoV016, another antibody-based therapy, in 268 patients. The combination therapy can reduce viral load, symptoms, emergency room visits, and hospitalizations, according to Lilly, which said it plans to submit the combination therapy for an EUA in November. Antibody-based treatments for COVID-19 have recently come into sharp focus since President Donald Trump last week was prescribed an experimental antibody treatment developed by Regeneron Pharmaceuticals Inc. . Lilly’s stock has gained 9.6% this year, in comparison to the S&P 500 , which is up 4.0%.
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