Kyverna reports one-year data for miv-cel in stiff person syndrome and myasthenia gravis

Kyverna Therapeutics announced on September 24, 2026 positive one-year topline data from KYSA-8, its registrational trial of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome (SPS), along with positive topline longer-term follow-up data from the Phase 2 portion of KYSA-6, its registrational trial in patients with generalized myasthenia gravis (gMG).¹

In the SPS trial, a database lock from July 2026 covers 12-month follow-up data on 26 patients with SPS, showing sustained improvement on the timed 25-Foot Walk test at month 12 (p < 0.0001), with median improvement from baseline of 46% at week 16 and 49% at month 12. Ninety-five percent of patients who had achieved a clinically meaningful improvement at the primary analysis maintained that benefit, and 92% remained free of chronic immunotherapies for SPS. No high-grade CRS, ICANS, or IEC-HS cases were reported.¹ Kyverna said it intends to include the one-year data in its rolling BLA submission, which remains on track for completion in Q4 2026.¹

For gMG, as of a June 2026 data cutoff in seven patients, follow-up now extends to one year and beyond in five patients, with all seven achieving clinically meaningful improvement in MG-ADL and QMG scores at 24 weeks, and improvements maintained through one year or longer in the five patients who reached that point.¹ Fifty-seven percent maintained minimal symptom expression at last follow-up, and 86% remained off immunosuppressants.¹

The Phase 3 portion of KYSA-6 is ongoing, with enrollment expected to complete in mid-2027.¹ Full SPS data will be presented at the joint ACTRIMS-ECTRIMS meeting in Toronto, October 21-23, 2026.¹