FDA forces Gilead Sciences to pause enrollment in U.S. leukemia drug trials
Gilead Sciences (NASDAQ:GILD) announced Monday that the U.S. Food and Drug Administration (FDA) had placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML).
A clinical hold is issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is «a delay or suspension of only part of the clinical work requested under the IND,» according to the FDA website.
Effective immediately, GILD will pause the screening and enrollment of new study participants under the IND application.
The move follows the previously announced decision to stop the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes.
Despite opening Monday's session lower, GILD shares are currently 0.2% above Friday's close, trading above the $76 per share mark.
The company said it is now working with regulatory authorities to specify the next steps to release the partial clinical hold.
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