Gilead to go again with magrolimab as FDA lifts partial clinical hold

Biotech major Gilead Sciences (Nasdaq: GILD) has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine.

Initially, the FDA placed the clinical hold on this combination in January due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.

"We continue to believe in the potential for this treatment to address the unmet medical needs faced by people living with MDS and AML"The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial, meaning that enrollment in the USA can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).