Kyverna Reports One-Year Miv-Cel Data From SPS and gMG Trials

Kyverna Therapeutics (NASDAQ:KYTX) reported one-year topline data from its KYSA-8 registrational trial of miv-cel, or mivocabtagene autoleucel, in stiff person syndrome (SPS), alongside longer-term follow-up results from the Phase 2 portion of its KYSA-6 trial in generalized myasthenia gravis (gMG).

The company said the latest results provide follow-up on clinical outcomes and safety measures after patients received a single dose of the investigational cell therapy.

KYSA-8 Reports 49% Median Improvement at 12 Months

The KYSA-8 trial enrolled 26 adults with SPS who received a single dose of miv-cel.

As of the July 2026 database lock, patients recorded a median 49% improvement from baseline in the timed 25-foot walk at month 12. This compared with a median improvement of 46% at week 16.

Among 12 patients who required a walking aid before treatment, 67% continued to walk without assistance at the one-year assessment, according to Kyverna.

The company also reported that 92% of patients remained free of chronic immunotherapies for SPS.

Kyverna said no high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) was reported in the trial.

The results are topline clinical trial findings reported by the company and do not establish regulatory approval of miv-cel.

BLA Submission Targeted for Fourth Quarter

Kyverna said its rolling Biologics License Application submission for miv-cel in SPS remains on schedule for completion during the fourth quarter of 2026.

The company plans to present the full KYSA-8 dataset at the joint ACTRIMS-ECTRIMS meeting in Toronto, scheduled for October 21 to 23, 2026.

Completion of the BLA submission would represent a regulatory filing and does not determine whether the therapy will ultimately receive approval.

KYSA-6 Provides Longer-Term gMG Follow-Up

Kyverna also reported longer-term results from seven patients treated with a single dose of miv-cel in the Phase 2 portion of its KYSA-6 trial in gMG.

As of the June 2026 data cutoff, all seven patients had achieved what the company described as clinically meaningful improvement on the MG-ADL and QMG co-primary endpoints at 24 weeks.

Five of the seven patients had reached at least one year of follow-up. Kyverna reported that 57% of the overall seven-patient group maintained minimal symptom expression.

Six of the seven patients remained off immunosuppressant therapies at their most recent follow-up, according to the company.

Kyverna also reported no high-grade CRS, ICANS or IEC-HS cases among the seven patients.

The KYSA-6 findings are based on a small Phase 2 patient group, and the longer-term follow-up period was available for five of the seven participants at the stated data cutoff.

Kyverna Therapeutics stock price