Gilead Sciences, Inc. (NASDAQ:GILD) said the Food and Drug Administration (FDA) has put a clinical hold on its studies evaluating its investigation anti-CD47 immunotherapy magrolimab for acute myeloid leukemia (AML), a month after the biopharmaceutical company discontinued a Phase 3 study of the drug for higher-risk myelodysplastic syndromes.
The firm said it has paused the screening and enrollment of patients in its trials, but patients already enrolled in the AML clinical studies can continue to receive treatment and be monitored per the existing study protocol.
Studies of magrolimab in solid tumors are not impacted, Gilead noted.
The company said it is working with regulatory bodies to determine the next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.
Gilead shares traded flat at US$75.93 mid-morning on Monday.
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