What happened
Shares of clinical-stage biopharmaceutical company Humanigen (HGEN) are soaring through the roof on Monday after the company reported positive top-line results from a clinical trial for one of its pipeline candidates, lenzilumab. As of 1:20 p.m. EDT, the company's stock was up by 66.6% after jumping by as much as 108.7% earlier today.
So what
Lenzilumab is an experimental treatment for COVID-19. In a phase 3 clinical trial on patients hospitalized with the disease, those who received lenzilumab and other treatments (including steroids and remdesivir, an antiviral medicine for COVID-19 marketed by Gilead Sciences), were 54% more likely to survive without the assistance of mechanical ventilation than those who received a placebo and other treatments.
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Also, lenzilumab was generally safe and well tolerated during the study. None of the serious adverse reactions observed in the trial were attributed to the medicine. According to Dr. Zelalem Temesgen, the principal investigator of the study, "The data strongly suggest that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia." With these positive results under its belt, Humanigen is gearing up to submit a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for lenzilumab.
Now what
Several COVID-19 medicines have already earned Emergency Use Authorization from regulatory authorities, including remdesivir and Eli Lilly's bamlanivimab. But there can never be enough effective treatments for a disease, particularly one that has caused a deadly worldwide pandemic. Lenzilumab looks likely to contribute meaningfully to Humanigen's top line, and given that the healthcare company currently has no products on the market, it is not surprising to see investors bid up its shares today.
