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Kyverna Therapeutics announced positive one-year topline data from its registrational KYSA-8 trial of miv-cel in stiff…
KYTXKyverna Therapeutics, Inc.
Kyverna Therapeutics announced positive one-year topline data from its registrational KYSA-8 trial of miv-cel in stiff person syndrome (SPS) and longer-term follow-up data from the Phase 2 portion of its KYSA-6 trial in generalized myasthenia gravis (gMG). In SPS, 95% of patients sustained clinically meaningful improvements at month 12, with 92% remaining free of chronic immunotherapies. In gMG, all seven patients maintained minimal symptom expression or better through one year or longer, and 86% remained off immunosuppressants. The company reported a consistent safety profile with no high-grade cytokine release syndrome or neurotoxicity. Kyverna confirmed its rolling Biologics License Application for SPS is on track for completion in the fourth quarter of 2026, while Phase 3 enrollment for gMG is expected to conclude by mid-2027. The company operates as a late-stage clinical immunology firm developing CAR T-cell therapies for neurologic autoimmune diseases.