HGEN - Humanigen begins rolling submission for lenzilumab in COVID-19 in U.K.

Humanigen (HGEN) has initiated a rolling review submission for Marketing Authorization ((MA)) by United Kingdom’s Medicines and Healthcare Products Regulatory Agency ((MHRA)) for its lead drug candidate, lenzilumab.This application follows Humanigen’s submission for Emergency Use Authorization ((EUA)) to the FDA. In the LIVE-AIR phase 3 clinical trial, lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of survival without ventilation compared to placebo.“Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients that remain at risk of COVID-19. Now, with applications in the US and in the UK, we feel we can help tackle this global challenge," said Cameron Durrant, MBA, MD, CEO of Humanigen.HGEN shares up 2.8% premarket trading at $21.70.

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Humanigen begins rolling submission for lenzilumab in COVID-19 in U.K.