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    Humanigen, Inc. (HGEN) Stock Trending Higher Following MHRA Acceptance of Lenzilumab Marketing Authorization Submission

    By ST Staff

    Jul 09,2021

    5:32 AM UTC

    Humanigen, Inc. (HGEN) stock prices were up by 1.96% as of the market closing on July 8th, 2021, bringing the price per share up to USD$16.65. Subsequent premarket fluctuations saw the stock rise by 17.24%, bringing it up to USD$19.52.

    Market Authorization Submission Accepted

    July 9th 2021 saw the company announce the acceptance of its Market Authorization submission of lenzilumab as a treatment for Covid-19, having begun in June 2021. The UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) gave the green light for accelerated Covid-related rolling review, with the assessment expected to occur on a short timescale than a standard rolling review.

    Working Towards the Acceptance

    HGEN held various meetings with different UK authorities in the time leading up to the initiation of the submission for Marketing Authorization. This included, but was not limited to, a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics Taskforce (TTF), the Dept. of Health and Social Care (DHSC), National Health Service England (NHSE), and the National Institute for Health and Care Excellence (NICE).

    Scope of Lenzilumab

    The proliferation of various strains of the coronavirus across the globe emphasize the continued need for effective treatments that can treat various strains for the millions that are still left unvaccinated. Despite an 86% first dose vaccination rate across the UK, current week-long hospitalization rates were nearly 2,500, a 45% increase over the prior period. Deaths in the UK resulting from Covid-19 were up to 161 over the prior week, a 40% increase from the numbers reported in the week before.

    Waiting Game

    The company continues to collaborate with its partners to situate themselves for the most effective distribution of lenzilumab, as they wait for the pending conditional approval of the use of the treatment in patients hospitalized because of Covid-19. With Market Authorization pending, HGEN is also waiting on Emergency Use Authorization in the United States. Should they be awarded concurrently, the company is preparing itself to ensure the appropriate allocation of the treatment in both the U.K and the U.S.

    Future Outlook for HGEN

    With the world hurtling towards global immunizations, HGEN is capitalizing on the available market space as newer variants of the coronavirus continue to devastate the globe. Current and potential investors are hopeful that the company will be able to leverage its resources to consolidate and expand its market footprint in order to usher in significant growth over the long term.

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