regulatory
confidence high
sentiment positive
materiality 0.70
FDA removes partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab
MACROGENICS INC
- FDA lifted partial clinical hold on Phase 2 LINNET study of lorigerlimab (bispecific DART targeting PD-1 and CTLA-4).
- Revised protocol includes additional risk-mitigation measures for potential hematologic and cardiac toxicities.
- MacroGenics plans to resume enrollment in gynecologic cancers (PROC and CCGC); 41 patients dosed to date.
- Existing participants continued receiving study drug during the hold; over 300 dosed across all lorigerlimab studies.
- Company remains on track to provide a mid-2026 clinical update on the program.