Kyverna Therapeutics, Inc. (KYTX) Sets SPS, MS Data Presentations; BLA Completion Targeted This Quarter

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 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.

Kyverna Therapeutics advances in autoimmune CAR T therapy despite setbacks at Novartis and Bristol Myers Squibb. Novartis paused trials after patient deaths, and BMS halted trials due to safety concerns. Kyverna's mivocabtagene autoleucel (miv-cel) shows promise in stiff person syndrome with a solid safety profile. The company aims to complete a BLA filing by year-end.