secwatch.observer — SEC 8-K summary
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Issuer:     Intellia Therapeutics, Inc. (NTLA)
CIK:        0001652130
Form:       8-K
Filed at:   2026-01-09T23:59:59+00:00
Accession:  0001193125-26-008307
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Intellia provides update on FDA clinical hold for nex-z after patient death in MAGNITUDE trial
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- Patient in MAGNITUDE Phase 3 trial for ATTR-CM died from septic shock secondary to perforated duodenal ulcer; autopsy supports clinical diagnoses.
- Grade 4 liver transaminase elevations reported in <1% of >650 enrolled MAGNITUDE patients; all other cases resolved within weeks.
- FDA clinical hold continues on MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) Phase 3 trials of nex-z.
- No Grade 4 liver events reported in MAGNITUDE-2 (47 patients enrolled with ATTRv-PN).
- Company plans to provide update after finalizing path forward with regulators.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/0001193125-26-008307-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/d15047d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-008307

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