Kyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person…

Kyverna Therapeutics (NASDAQ:KYTX) reported Phase 1 trial data for miv-cel in progressive MS patients. Five of six showed stable or improved disability scores, with four sustaining benefits for over a year. The treatment showed CAR T-cell expansion and B-cell depletion, with no high-grade safety issues. Stanford's Jeffrey Dunn noted the unmet need for progressive MS therapies. Kyverna aims to update its strategy by early 2027.

Kyverna Therapeutics (KYTX) shared updated Phase 1 trial results for miv-cel in progressive MS, showing CNS penetration, disability score improvements, durable benefits, and a well-tolerated safety profile. The treatment has received RMAT designation for non-active SPMS.

Kyverna Therapeutics (KYTX) reported promising Phase 1 trial data for miv-cel in progressive multiple sclerosis, showing sustained clinical benefits and robust CAR T-cell penetration in the CNS. The treatment demonstrated a well-tolerated safety profile and received RMAT designation for non-active secondary progressive MS, with a development update expected by early 2027.

Kyverna Therapeutics (KYTX) reported Phase 2 trial data showing sustained benefits of miv-cel in stiff person syndrome. Among 26 patients, walking performance improved by 49% and 92% remained free of chronic immunotherapies. No high-grade CRS or ICANS cases were reported. KYTX shares are trading at $5.97, down 1.16%.

Kyverna Therapeutics' experimental CAR T-cell therapy, mivocabtagene autoleucel (miv-cel), showed lasting improvements in stiff person syndrome (SPS) patients in a phase 2 trial led by CU Anschutz. One year post-treatment, patients demonstrated significant mobility improvements, reduced muscle stiffness, and less dependence on walking aids. Kyverna plans to submit a BLA in Q4 2026, potentially making miv-cel the first FDA-approved treatment for SPS.

Kyverna Therapeutics (KYTX) reported one-year data from its KYSA-8 trial of miv-cel, a CAR T-cell therapy for stiff person syndrome. 77% of patients showed at least 20% improvement in mobility, and 67% of patients no longer needed walking aids. The trial met all secondary endpoints, with no high-grade cytokine release syndrome or neurotoxicity reported.