: Gilead says FDA hits pause on study of leukemia treatment

Gilead Sciences Inc. GILD said Monday that the U.S. Food and Drug Administration has put a partial clinical hold on U.S. studies evaluating a treatment for acute myeloid leukemia. Screening and enrollment of new participants in the study of magrolimab will be paused effective immediately, Gilead said in a release, while patients already enrolled in acute myeloid leukemia clinical studies can continue receiving treatment. The FDA’s move followed a previously announced discontinuation of a phase 3 study of magrolimab in higher-risk myelodysplastic syndromes, Gilead said. Studies of magrolimab in solid tumors are not impacted by the FDA’s action, the company said. Gilead said it is working with regulators to determine next steps for releasing the partial clinical hold. Gilead shares were roughly flat premarket on Monday and have dropped 11.6% in the year to date, while the S&P 500 SPX has gained 13.8%.

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