FDA Pauses Gilead's Investigational Magrolimab Study In Blood Cancer Patients
Portfolio Pulse from Vandana Singh
The FDA has placed a partial clinical hold on Gilead Sciences Inc's (NASDAQ:GILD) initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML). This follows the discontinuation of Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS). Gilead is working with regulatory authorities to determine the next steps to release the partial clinical hold.
August 21, 2023 | 3:46 pm
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Gilead's stock may be negatively impacted in the short term due to the FDA's partial clinical hold on its magrolimab study.
The FDA's decision to place a partial clinical hold on Gilead's magrolimab study could lead to delays in the drug's development and potential approval, which could negatively impact Gilead's stock in the short term.
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