Kyverna Therapeutics Inc. (NASDAQ:KYTX) announced 12-month topline results from two trials evaluating its miv-cel cell therapy in neurological autoimmune conditions.
The late-stage clinical immunology company highlighted strong, durable efficacy data in patients with stiff-person syndrome and generalized myasthenia gravis (gMG).
Stiff-person syndrome is a rare, progressive neurological and autoimmune disorder characterized by severe muscle stiffness and painful spasms.
gMG is a chronic autoimmune neuromuscular disorder that causes widespread, fluctuating weakness.
Positive 12-Month Outcomes In Stiff Person Syndrome Trial
The KYSA-8 registrational study met its primary and key secondary endpoints with statistical significance.
As of a July 2026 database lock, 12-month follow-up data from 26 patients with stiff person syndrome demonstrated a 49% median improvement in timed 25-Foot Walk performance compared to baseline.
Most trial participants sustained their progress, with 95% of those who achieved meaningful initial improvements maintaining their clinical benefits at month 12.
Furthermore, over one-third of patients completed the walk test in under five seconds, reaching speeds typical for healthy adults. Of the 12 patients who required walking assistance before treatment, 67% continued without needing aid.
Additionally, 92% of participants remained free from chronic immunotherapies.
The treatment maintained a well-tolerated safety profile with no high-grade cytokine release syndrome, neurotoxicity, or hemophagocytic lymphohistiocytosis-like syndrome observed.
Kyverna remains on track to complete its rolling Biologics License Application submission in the fourth quarter of 2026 using these 12-month data.
Long-Term Response In Generalized Myasthenia Gravis Study
Extended follow-up data from the Phase 2 portion of the KYSA-6 trial demonstrated deep and durable clinical responses in generalized myasthenia gravis patients.
As of June 2026, all seven participants achieved meaningful improvements in daily living activities and overall disease severity at 24 weeks following a single dose.
Five patients tracked for one year or longer sustained these improvements across all clinical score measures.
Furthermore, 57% of participants maintained minimal symptom expression at their last follow-up, while 86% remained off immunosuppressive therapies.
Kyverna expects to complete enrollment for the ongoing Phase 3 portion of the KYSA-6 study in mid-2027.
KYTX Price Action: Kyverna Therapeutics shares were down 0.92% at $7.81 at the time of publication on Thursday, according to Benzinga Pro data.
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