HGEN - Humanigan surges on positive Phase 3 data for COVID-19 therapy

Humanigen (HGEN) has added ~43.8% in the pre-market after announcing that its lead drug candidate against COVID-19, lenzilumab achieved the primary endpoint in a Phase 3 study in patients who were hospitalized with COVID-19 pneumonia.In the randomized trial, the patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a statistically significant 54% more chance of survival without the need for IMV (invasive mechanical ventilation) compared to placebo and other treatments.“The trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population,” commented CEO Cameron Durrant.“Our next step is to submit an application for Emergency Use Authorization to the Food and Drug Administration as soon as possible.”The primary endpoint was ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95% CI: 1.03-2.33, p=0.0365).The Kaplan-Meier estimate for IMV and/or death: 15.6% (95%CI: 11.5-21.0) in the lenzilumab arm versus 22.1%

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Humanigan surges on positive Phase 3 data for COVID-19 therapy