secwatch.observer — SEC 8-K summary
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Issuer:     Kyverna Therapeutics, Inc. (KYTX)
CIK:        0001994702
Form:       8-K
Filed at:   2026-09-24T10:00:27+00:00
Accession:  0001193125-26-400062
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Kyverna reports durable 1-yr SPS and gMG data; BLA on track Q4 2026
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- KYSA-8 SPS (n=26): median T25FW improvement 49% at 12 mo; 92% off chronic immunotherapies; no high-grade CRS/ICANS/IEC-HS.
- KYSA-6 gMG (n=7): 100% achieved clinically meaningful MG-ADL/QMG improvement at 24 wks; 57% maintained MSE; 86% off immunosuppressants.
- Rolling BLA for miv-cel in SPS on track for Q4 2026 completion; gMG Phase 3 enrollment expected mid-2027.
- Data to be presented at MS Toronto (Oct 21-23, 2026) and AANEM (Sept 29, 2026).
- Safety profile consistent: no high-grade CRS/ICANS and no IEC-HS across both trials through 1-yr follow-up.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1994702/000119312526400062/0001193125-26-400062-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1994702/000119312526400062/kytx-20260924.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-400062

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