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Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026

  • Kyverna Therapeutics announced two abstracts selected for presentation at the MSToronto2026 meeting in Toronto, Canada, from October 21-23, 2026.
  • Full one-year results from the KYSA-8 registrational trial in stiff person syndrome (SPS) will demonstrate sustained clinical benefit & a well-tolerated safety profile with no high-grade CRS, ICANS, or IEC-HS cases.
  • Updated Phase 1 investigator-initiated trial data for progressive multiple sclerosis will continue to highlight encouraging clinical activity & a well-tolerated safety profile.
  • CEO Warner Biddle stated the company is advancing toward completing its Biologics License Application (BLA) for miv-cel in SPS this quarter & laying groundwork for a commercial launch.
  • If approved, miv-cel would become the first CAR T-cell therapy for an autoimmune disease & the first approved treatment for SPS.
  • A poster presentation on the 1-year analysis of KYSA-8 will be delivered by Dr. Amanda Piquet on October 21, 2026.
  • An oral presentation on safety & preliminary efficacy in progressive multiple sclerosis will be delivered by Dr. Jeff Dunn on October 23, 2026.
  • No FDA-approved treatments currently exist for SPS, which impacts an estimated 6,000 patients in the U.S. & often leads to permanent disability or mortality.
  • Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy designed to achieve deep B-cell depletion & durable drug-free remission with a single dose.
  • More than 100 patients have been treated with miv-cel across various autoimmune diseases to date, showing a consistent safety profile.
  • The company holds three FDA Regenerative Medicine Advanced Therapy (RMAT) designations for miv-cel in SPS, generalized myasthenia gravis, & non-active secondary progressive multiple sclerosis.