other material
confidence high
sentiment positive
materiality 0.85
Kyverna's miv-cel meets all endpoints in KYSA-8 SPS trial; median T25FW improvement 46% (p=0.0003)
Kyverna Therapeutics, Inc.
- Single-dose miv-cel achieved statistically significant improvements across all primary and secondary endpoints at Week 16.
- 81% of patients achieved ≥20% improvement in T25FW; 67% of walking-aid users no longer needed assistance.
- All 26 patients discontinued chronic immunotherapies through last follow-up; no high-grade CRS or ICANS observed.
- Company plans to submit BLA for miv-cel in SPS; data also support potential in myasthenia gravis.
- Natural history study of 153 SPS patients showed minimal improvement with current treatments, underscoring unmet need.