other material
confidence high
sentiment positive
materiality 0.80
Kyverna reports durable 1-yr SPS and gMG data; BLA on track Q4 2026
Kyverna Therapeutics, Inc.
- 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.