secwatch.observer — SEC 8-K summary
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Issuer:     Intellia Therapeutics, Inc. (NTLA)
CIK:        0001652130
Form:       8-K
Filed at:   2026-09-08T20:05:15+00:00
Accession:  0001193125-26-385194
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Intellia's lonvo-z BLA accepted by FDA with Priority Review for HAE; PDUFA March 10, 2027
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- FDA accepted BLA for lonvo-z (formerly NTLA-2002) for HAE with Priority Review; PDUFA target date March 10, 2027.
- No advisory committee currently planned; if approved, lonvo-z would be first in vivo CRISPR therapy and only one-time HAE treatment.
- Phase 3 HAELO (80 patients): 87% reduction in mean monthly attacks vs placebo (p<0.0001) during weeks 5-28.
- 62% of lonvo-z patients attack-free and therapy-free for 6 months vs 11% placebo (p<0.0001).
- No serious adverse events in lonvo-z arm; most common TEAEs were infusion-related reactions, headache, fatigue, back pain.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/0001193125-26-385194-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-385194

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