secwatch.observer — SEC 8-K summary
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Issuer:     FATE THERAPEUTICS INC (FATE)
CIK:        0001434316
Form:       8-K
Filed at:   2025-10-27T23:59:59+00:00
Accession:  0001193125-25-250674
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FT819 SLE data: 10 patients show durable responses; expansion cohorts; pivotal study planned 2026
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- 10 SLE patients treated; 2 with lupus nephritis achieved CRR at 6 months; 1 in DORIS at 15 months.
- No dose-limiting toxicities, low-grade CRS, no ICANS or GvHD; supports same-day discharge plans.
- Initiated dose-expansion cohorts in AAV, IIM, and SSc; engaging FDA for registrational study design with pivotal study goal in 2026.
- Approximately 600 cryopreserved FT819 bags in inventory available for patient treatment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434316/000119312525250674/0001193125-25-250674-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434316/000119312525250674/d36426d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-250674

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