Gilead announces FDA partial hold on leukemia trial
Justin Sullivan/Getty Images News

Gilead Sciences (NASDAQ:GILD) announced Monday that the FDA placed a partial clinical hold on trials for its anti-CD47 immunotherapy, magrolimab, targeted at patients with acute myeloid leukemia.
Accordingly, the company will be barred from enrolling new patients in the U.S.-based trials for the candidate. However, the patients already enrolled in the trial will continue to receive magrolimab and be evaluated, Gilead (GILD) said.

The company said that the FDAâs decision would not impact studies for magrolimab in solid tumors, and discussions are underway to determine the steps required to ease the partial hold and enroll new patients.

The FDAâs partial clinical hold comes after the company terminated its Phase 3 ENHANCE study for the candidate in higher-risk myelodysplastic syndromes in June, citing a low probability of success.



More on Gilead 

Gilead Sciences: Mixed Signals, Again
Gilead Sciences Q2 Earnings: 'Transitional' Quarter Delivers Mixed Results

Gilead Sciences, Inc. (GILD) Q2 2023 Earnings Call Transcript
Gilead: Assessing How Shares Will Trade Over Upcoming Months (Technical Analysis)
Gilead and Tentarix partner to develop protein therapeutics
Seeking Alphaâs Quant Rating on Gilead Sciences