Humanigen (HGEN) shares as much as more than doubled Monday after the biopharmaceutical company reported progress with a COVID-19 treatment.
The stock recently traded at $21.55, up 54%. It has traded on Monday as high as $29.20, more than double its Friday close at $13.99.
The Burlingame, Calif., company’s lenzilumab is designed to treat the immune hyperresponse called cytokine storm that hits some COVID victims.
It said it would apply to the U.S. Food and Drug Administration for emergency-use authorization for the drug as soon as possible, it said.
Humanigen reported “positive top-line results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19.”
The trial demonstrated that patients who received lenzilumab and other treatments, including steroids and/or Gilead’s (GILD) remdesivir, had a 54% greater relative likelihood of survival without the need for ventilation compared with patients receiving placebo and other treatments, Humanigen said.
“The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes" in hospitalized COVID-19 patients with low oxygen in their tissues "who had not yet progressed to the point of requiring [intermittent mandatory ventilation],” said Cameron Durrant, Humanigen’s CEO.
“Additionally, 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.”
But Rochelle Walensky, a physician who directs the Centers for Disease Control and Prevention, also said the U.S. was facing "impending doom" from rising cases of the disease.