Gilead Sciences Announces Partial Clinical Hold on Acute Myeloid Leukemia Treatment Studies
Gilead Sciences announces FDA's partial clinical hold on acute myeloid leukemia treatment studies, pausing new participant enrollment.
Gilead Sciences Inc. has announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on U.S. studies evaluating a treatment for acute myeloid leukemia. This development has prompted Gilead to pause the screening and enrollment of new participants in the study of magrolimab, effective immediately.
Existing patients already enrolled in acute myeloid leukemia clinical studies will continue to receive treatment without interruption. However, Gilead has disclosed that the FDA's action follows the termination of a phase 3 study of magrolimab in higher-risk myelodysplastic syndromes.
Fortunately, this hold does not impact studies of magrolimab in solid tumors, ensuring research in this area can proceed unaffected. Gilead has reassured that it is actively collaborating with regulators to assess the next steps for resolving the partial clinical hold.
Despite these recent developments, Gilead shares remained relatively stable in premarket trading on Monday. However, the company has experienced an 11.6% decline in stock value year-to-date, while the S&P 500 index has shown a 13.8% increase.