HGEN - Humanigen submits lenzilumab COVID-19 EUA application to FDA

Humanigen (HGEN) announces that the company has submitted an application to the U.S. FDA requesting Emergency Use Authorization ((EUA)) for lenzilumab for the treatment of patients hospitalized with COVID-19.The EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation ((SWOV)) in newly hospitalized COVID-19 patients.In the study, Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo.Shares up nearly 4% premarket.Humanigen and Chime Biologics entered into a manufacturing services agreement to produce lenzilumab's bulk drug substance and drug product, earlier this month.

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Humanigen submits lenzilumab COVID-19 EUA application to FDA