Humanigen Files US Emergency Use Application For Lenzilumab For COVID-19

Humanigen Inc HGEN has submitted an application to the FDA seeking Emergency Use Authorization (EUA) for lenzilumab to treat patients hospitalized with COVID-19.
The application is based on 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.
Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo.
Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir.
No serious adverse events were attributed to lenzilumab, and the overall safety profile was comparable to placebo.
Price Action: HGEN shares are down 8.2% at $20.87 during the market session on the last check Friday.