MacroGenics Study on Pause After Safety Issues

By Katherine Hamilton


MacroGenics said the Food and Drug Administration placed a hold on a trial after safety events occurred in enrolled patients.

The Rockville, Md., biopharmaceutical company said Monday it had paused enrollment on a Phase 2 study of lorigerlimab as a treatment for gynecological cancer.

The FDA's hold was initiated after MacroGenics notified the agency of a pause in enrollment due to recent safety events.

The safety events occurred in four patients and included Grade 4 thrombocytopenia, myocarditis and neutropenia and concurrent septic shock.

To date, 41 study participants have been dosed every three weeks. Enrolled patients can continue to receive the study drug, but no new patients will be enrolled.

Shares fell 8.6% to $1.60 in after-hours trading.


Write to Katherine Hamilton at katherine.hamilton@wsj.com


(END) Dow Jones Newswires

February 23, 2026 19:04 ET (00:04 GMT)

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