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# FDA Partial Hold on Gilead’s Magrolimab
- URL: https://www.fdaweb.com/fda-partial-hold-on-gileads-magrolimab/
- Published: 2023-08-21T12:00:00.000Z
- Updated: 2026-09-14T18:51:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155140

FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating magrolimab to treat acute myeloid leukemia (AML). The hold, which applies to new patients entering magrolimab studies, follows the company’s recent announcement that it is discontinuing the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes. Patients already enrolled in AML studies are not affected by the agency’s action, the company says.

Gilead says it is working with FDA and other regulatory authorities to determine next steps to release the partial hold. Magrolimab is described by the company as a potential first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPa receptor on macrophages.