One-Year Benefits Sustain Momentum For Kyverna's Autoimmune CAR-T Therapy; Stock Up

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.

Kyverna Therapeutics (KYTX) reported 1-year data from its KYSA-8 trial, showing sustained clinical benefit and deep B-cell depletion with miv-cel in stiff person syndrome. The treatment had a well-tolerated safety profile, with no high-grade CRS or ICANS reported. The data confirms earlier signals of efficacy and safety, with potential for FDA review and approval.

Kyverna Therapeutics (KYTX) reported one-year data from its KYSA-8 trial of miv-cel for stiff person syndrome (SPS). 20/26 patients showed meaningful walking improvements, and 24/26 remained off chronic immunotherapies. The trial met all primary and secondary endpoints, with a well-tolerated safety profile. Kyverna aims to make miv-cel the first approved therapy for SPS.

Kyverna Therapeutics (KYTX) will present 1-year SPS trial results and updated MS data at MSToronto2026. The company expects to complete its rolling BLA for miv-cel in SPS this quarter, according to the announcement.

Kyverna Therapeutics (KYTX) will present data at MSToronto2026 showing sustained benefits and a well-tolerated safety profile for its CAR T-cell therapy, miv-cel, in stiff person syndrome and progressive multiple sclerosis. The company expects to complete its BLA submission for SPS this quarter, potentially leading to the first approved treatment for the condition.