secwatch.observer — SEC 8-K summary
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Issuer:     MACROGENICS INC (MGNX)
CIK:        0001125345
Form:       8-K
Filed at:   2026-02-24T23:59:59+00:00
Accession:  0001125345-26-000009
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab after severe safety events
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- Partial hold halts new enrollment; current participants may continue receiving lorigerlimab.
- Safety events across 4 patients: Grade 4 thrombocytopenia (2), myocarditis (1), neutropenia with septic shock (1) leading to 1 death (Grade 5).
- 41 patients dosed at 6 mg/kg every 3 weeks in platinum-resistant ovarian and clear cell gynecologic cancer cohorts.
- MacroGenics commits to working with FDA to resolve the hold and resume enrollment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1125345/000112534526000009/0001125345-26-000009-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1125345/000112534526000009/mgnx-20260223.htm
  HTML page:      https://secwatch.observer/filing/0001125345-26-000009

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