Kyverna Therapeutics Released Topline Data From KYSA-8 Phase 2 Trial Of Mivocabtagene Autoleucel For Stiff Person Syndrome, Miv-Cel Achieved Statistically Significant Clinical Benefit Across All Primary And Secondary Endpoints

Benzinga·12/15/2025 11:33:03

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Landmark results could pave the way for miv-cel to become the first FDA-approved CAR T-cell therapy for autoimmune disease; Company on track to submit BLA for stiff person syndrome in 1H 2026
Miv-cel achieved statistically significant clinical benefit across all primary and secondary endpoints, reversing disability and eliminating immunotherapies after a single dose
Miv-cel was generally well-tolerated with no high-grade CRS or ICANS observed