FDA has placed a partial clinical hold on Gilead Sciences Inc (NASDAQ:GILD) initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML).
The FDA action follows the previously announced discontinuation of Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).
Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused.
According to the study protocol, patients already enrolled in AML clinical studies may continue to receive treatment and be monitored.
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Studies of magrolimab in solid tumors will continue without any impact from the FDA action.
Gilead said it is working with regulatory authorities to determine the following steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.
In January 2022, The FDA placed a partial clinical hold on Gilead’s studies evaluating the combination of magrolimab plus azacitidine.
In April, the FDA lifted the partial clinical hold after reviewing the comprehensive safety data from each trial.
GILD Price Action: Gilead shares were down 0.43% at $75.55 at the time of publication Monday.
