Gilead Sciences, Inc. is keeping mum about what prompted a partial clinical hold on its program to develop magrolimab in combination with Bristol Myers Squibb Company’s Vidaza (azacitidine), apart from an imbalance in adverse events. But whatever the culprit, further delays in the program caused by the hold could erode Gilead’s lead in an increasingly crowded field of CD47-targeting drugs.
Gilead said 25 January that the US Food and Drug Administration placed a partial clinical hold on studies evaluating magrolimab/Vidaza due to “an apparent imbalance” in investigator-reported suspected unexpected serious adverse reactions (SUSAR) between study arms