- Humanigen Inc (NASDAQ: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.
Icosavax Shares Plummet Following Interim Results From Initial-Stage RSV Vaccine Study
Icosavax (NASDAQ: ICVX) announced interim results from its Phase 1/1b clinical trial of IVX-121, respiratory syncytial virus (RSV) F antigen, in young and older adults.
The Phase 1/1b clinical trial is designed to evaluate the safety and immunogenicity of three dose levels of IVX-121.
