Magrolimab trial failure followed by partial clinical hold
Gilead Sciences (Nasdaq; GILD) has been hit with a partial clinical hold by the US Food and Drug Administration (FDA) on the initiation of new patients in US studies evaluating magrolimab to treat acute myeloid leukemia (AML).
The news comes a month after the US biotech company announced that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.
Following the clinical hold, screening and enrollment of new study participants under the US investigational new drug application and US Expanded Access Program will be paused, effective immediately.
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