Humanigen Inc said on Monday its experimental COVID-19 drug met the main goal of improved survival without the need for mechanical ventilation in hospitalized patients in a late-stage trial, sending its shares soaring 60% before the opening bell.
The company said it plans to submit an application for emergency use authorization (EUA) for its drug, lenzilumab, "as soon as possible".
"We have already established some meetings with FDA over next couple of weeks, to better understand what would be necessary to submit an EUA application," Chief Executive Officer Cameron Durrant told Reuters.
Humanigen's lenzilumab belongs to a class of drugs known as monoclonal antibodies (MAbs), which are manufactured copies of proteins produced by the body to fight coronavirus infection.
The company lags behind Regeneron Pharmaceuticals Inc and Eli Lilly and Co, COVID-19 MAbs from which have already received EUAs from the health regulator.
Humanigen said patients receiving lenzilumab in combination with other treatments including steroids and Gilead Inc's remdesivir, were 54% were more likely to survive without mechanical ventilation versus patients on placebo through 28 day.
Humanigen has entered several manufacturing deals to expand production capacity for lenzilumab.
"We are scaling up our manufacturing and we hope to have enough therapies to be able to treat 100,000 patients over course of the next 12 months," CEO Durrant said.
Lenzilumab is also being tested in a National Institutes of Health-backed study in COVID-19 patients on mechanical ventilation.
Shares of the California-based pharmaceutical company were up 60% at $22.40 in premarket trading.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)
