secwatch.observer — SEC 8-K summary
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Issuer:     MACROGENICS INC (MGNX)
CIK:        0001125345
Form:       8-K
Filed at:   2026-04-08T23:59:59+00:00
Accession:  0001125345-26-000026
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA removes partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1125345/000112534526000026/0001125345-26-000026-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1125345/000112534526000026/mgnx-20260408.htm
  HTML page:      https://secwatch.observer/filing/0001125345-26-000026

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer