What happened
Shares of Humanigen (HGEN) were vaulting 10.8% higher as of 2:47 p.m. EDT on Wednesday. The gain came after the company announced the publishing of results from a phase 3 study evaluating lenzilumab in treating hospitalized COVID-19 patients on the online preprint site medRxiv.
So what
The late-stage study found that lenzilumab significantly improved survival without ventilation for hospitalized patients with COVID-19 compared to standard treatments of Gilead Sciences' remdesivir and/or corticosteroids by themselves. Patients with especially high inflammation levels and those under the age of 85 experienced the greatest benefit from receiving Humanigen's experimental therapy.
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Humanigen reported top-line results in late March from its phase 3 study of lenzilumab in treating hospitalized COVID-19 patients. The company stated at that time that it planned to submit the results for potential publication in a peer-reviewed journal. The online mexRxiv site offers a way for researchers to share data before it's reviewed by peers. The additional details provided in the online preprint gave investors more confidence about the prospects for lenzilumab in treating COVID-19.
Now what
In March, Humanigen CEO Cameron Durrant said that the company planned to submit an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for lenzilumab in treating COVID-19. Winning EUA for the experimental therapy would likely provide yet another major catalyst for the biotech stock.
