Miv-cel (mivocabtagene autoleucel, KYV-101) - (KYSA-6)

September 24, 2026: Kyverna Therapeutics (NASDAQ: KYTX) reported positive longer-term topline data for miv-cel (mivocabtagene autoleucel, KYV-101) from two registrational programs. In KYSA-8 in stiff person syndrome (SPS), 12-month follow-up in 26 patients showed sustained timed 25-Foot Walk benefit: median improvement was 46% at week 16 and 49% at month 12 (p<0.0001); 95% of patients with clinically meaningful benefit at primary analysis maintained it, 67% of prior walking-aid users no longer required assistance, secondary endpoints remained significant, and 92% remained free of chronic SPS immunotherapies. The company said the rolling BLA for SPS remains on track for completion in Q4 2026; full data will be presented at MS Toronto/ACTRIMS-ECTRIMS on October 21-23, 2026.

In KYSA-6 Phase 2 in generalized myasthenia gravis (gMG), as of June 2026 cutoff (n=7), all patients achieved clinically meaningful improvement in MG-ADL and QMG at 24 weeks, with mean reductions of -8.3 and -11.7 points. In five patients followed for at least one year, improvements in MG-ADL, QMG, and MGC were maintained; 57% maintained minimal symptom expression, and 86% remained off immunosuppressants at last follow-up. Safety across both trials remained favorable, with no high-grade CRS, no ICANS, and no IEC-HS. Additional KYSA-6 data will be presented at AANEM on September 29, 2026; Phase 3 enrollment is expected to complete in mid-2027.