FDA Lifts Partial Clinical Hold on MacroGenics Phase 2 LINNET Study of Lorigerlimab

On April 8, 2026, MacroGenics announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the Phase 2 LINNET study of lorigerlimab. Lorigerlimab is an investigational bispecific DART molecule targeting PD-1 and CTLA-4, currently being evaluated for the treatment of gynecologic cancers, including platinum-resistant ovarian cancer and clear cell gynecologic cancer. Under the partial hold, previously enrolled patients were permitted to continue treatment, but new enrollment was paused. With the hold lifted, MacroGenics plans to resume enrollment of new participants under a revised protocol. This updated protocol incorporates additional risk-mitigation measures specifically designed to monitor and manage potential hematologic and cardiac toxicities. To date, 41 patients have been dosed in the LINNET study, contributing to a total of over 300 patients treated with lorigerlimab across all clinical trials. The company remains on track to provide a mid-year clinical update for the program in 2026.