FDA puts partial clinical hold on Gilead's magrolimab + azacitidine studies

  • Gilead Sciences (NASDAQ:GILD) announces that the FDA has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in suspected unexpected serious adverse reactions (SUSARs) between study arms.
  • While no clear trend in the adverse reactions or new safety signal has been identified at this time, the partial clinical hold is being implemented by Gilead Sciences across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.
  • During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine.
  • Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.
  • Recently, FDA expanded use of Gilead Sciences 's COVID drug remdesivir to non-hospitalized patients.

    Over the current book year the total revenue from the company in Foster City will be 24.53 billion USD (consensus estimates). This is quite lower than 2021's revenue of 27.31 billion USD.

    Historical revenues and results Gilead Sciences plus estimates 2021

    koersdata

    The analysts expect for 2021 a net profit of 8.22 billion USD. For this year the majority of the analysts, consulted by press agency Thomson Reuters, expects a profit per share of 6.53 USD. The PE-ratio therefore is 8.87.

    Huge dividend Gilead Sciences

    Analysts expect a dividend of 2.92 USD per share. Gilead Sciences 's dividend yield thus equals 5.04 percent. The average dividend yield of the biotech companies equals a relatively high 2.64 percent.

    Gilead Sciences 's market capitalization is based on the number of outstanding shares around 72.63 billion USD. -4

    On Thursday, the stock closed at 57.92 USD.

    Historical stock prices Gilead Sciences

    historical stocks gileadsciences

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