KYTX · Kyverna Therapeutics, Inc.

Kyverna Therapeutics reported positive primary analysis results from its registrational Phase 2 trial KYSA-8 evaluating miv-cel (mivocabtagene autoleucel) in stiff person syndrome (SPS). The single-arm trial enrolled 26 patients with inadequate response to prior immunomodulatory therapies. The primary endpoint of change from baseline in Timed 25-Foot Walk (T25FW) at Week 16 was met with statistical significance (p=0.0003), showing a median improvement of 46%. Notably, 81% of patients achieved clinically meaningful improvement (≥20% reduction), and 67% of those requiring walking aids at baseline no longer needed assistance at Week 16. All secondary endpoints (mRS, HAI, DSI, HSS) also showed significant improvements (p<0.0001). All patients discontinued chronic immunotherapies and remained free through last follow-up. Safety was well-tolerated with no high-grade CRS or ICANS; Grade 3/4 neutropenia occurred in four patients and was manageable. The company plans to submit a BLA for miv-cel in SPS, which currently has no FDA-approved treatments. Management highlighted the potential for miv-cel to fundamentally change the treatment paradigm. The data were presented at the AAN Annual Meeting, and a conference call is scheduled for April 22, 2026.