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Incyte Drug Misses Endpoint in COVID-Respiratory-Distress Trial

Incyte's Phase 3 study of ruxolitinib missed its primary endpoint of preventing patient deaths from COVID-related acute respiratory distress syndrome.

Incyte (INCY) - Get Free Report shares were higher on Friday after the biopharma said that in a clinical trial its ruxolitinib missed its key endpoint of preventing deaths among patients with COVID-19-related acute respiratory distress syndrome.

Ruxolitinib, marketed by Incyte as Jakafi, is cleared by the Food and Drug Administration to treat polycythemia vera, a type of cancer that occurs when too many red blood cells are made in the bone marrow.

Shares of the Wilmington, Del., company at last check rose 0.92% to $79. The company reported the results after the close of trading on Thursday.

The trial evaluated the efficacy and safety of ruxolitinib plus standard of care in patients on mechanical ventilation with COVID-19-associated ARDS.

The results indicated "a trend towards an improvement in mortality," the company added. 

“There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe COVID-19 related complications, specifically those requiring mechanical ventilation,” said Steven Stein, chief medical officer, Incyte in a statement.

The company has been working to expand Jakafi’s scope, testing it for the treatment of solid tumors and advanced malignancies. 

“We hope the results of this study, and the potential utility of ruxolitinib for the treatment of patients with severe COVID-19 associated ARDS will contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the health-care system," Stein added.

Incyte plans to make ruxolitinib available to eligible patients in the U.S. at no cost via an expanded access program, pending agreement with the FDA. 

Incyte provides anatomic diagnostic services. The company offers services for dermatopathology, gastrointestinal and gynecologic pathology, hematopathology, oral and maxillofacial pathology, renal pathology, and urologic pathology.