KYSA-8 trial demonstrates positive topline data for miv-cel in stiff person syndrome

Kyverna Therapeutics/KYV-101 (miv-cel)

Kyverna announced positive topline data from KYSA-8, enrolling 26 patients with stiff person syndrome. Primary endpoint (Timed 25-Foot Walk) was met with p=0.0003 improvement. At month 12, median improvement was 49% and 95% of patients sustained clinically meaningful response. All secondary endpoints achieved p<0.0001. No high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity observed. Company initiated rolling BLA submission.