Humanigen's (NASDAQ: HGEN) stock is up almost 13% premarket after the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) accepted its submission for marketing authorisation n for lenzilumab in COVID-19.
The submission has been accepted for an expedited COVID-related rolling review, with an assessment expected to occur more rapidly than a standard rolling review.
Leading up to the submission last month, Humanigen had several meetings with regulatory bodies in the UK, including a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics TaskForce, the Department of Health and Social Care, National Health Service England and the National Institute for Health and Care Excellence.
“We are grateful this submission will receive expedited consideration by MHRA,” said Cameron Durrant, CEO of Humanigen.
“The global spread of variants of concern, such as the Delta variant, highlights the continued need for proven therapies that are variant-agnostic for millions who remain at risk of COVID-19,” he added.
Humanigen's shares are up 13.21% premarket at $18.85, regaining some of its year to date losses.
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