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8-K2026-04-22· grok-4-1-fast-non-reasoning

KYTX · Kyverna Therapeutics, Inc.

0001193125-26-168287

SEC filing

Summary

Kyverna Therapeutics announced positive primary analysis from KYSA-8 registrational trial of miv-cel in stiff person syndrome and longer-term Phase 2 data from KYSA-6 in generalized myasthenia gravis on April 20-21, 2026.

Key takeaways

Full analysis

Kyverna Therapeutics disclosed positive topline data from two key neuroimmunology programs via press releases on April 20 and 21, 2026, under Item 7.01 Regulation FD. The KYSA-8 registrational trial in stiff person syndrome (SPS), a debilitating condition with no FDA-approved therapies, met its primary endpoint of significant T25FW improvement with a 46% median reduction at Week 16. Notably, 81% of patients achieved ≥20% improvement, 31% showed 4-fold improvement, and Week 16 scores approached healthy adult levels. All patients were 100% free of immunotherapies from Week 16 onward, supported by robust miv-cel expansion, complete B-cell depletion, and 56% median reduction in GAD65-IgG autoantibodies. This reinforces miv-cel's potential as first-in-class CAR T for autoimmune diseases, with BLA preparations underway for SPS, a valuable market opportunity. In parallel, longer-term data from the Phase 2 portion of KYSA-6 in generalized myasthenia gravis (gMG) showed deepening responses out to 52 weeks, with 100% of patients immunotherapy-free up to 24 weeks across MG-ADL, QMG, and MGC scales, and majority achieving minimal symptom expression. These results bolster confidence in the ongoing Phase 3 gMG trial. Miv-cel, a fully human CD19 CAR T with CD28 costimulation, demonstrated no high-grade CRS or ICANS across over 100 patients dosed. The company is hosting a conference call today with slides in Exhibit 99.1 to detail findings, positioning Kyverna to potentially deliver the first approved autoimmune CAR T and transform treatment paradigms with durable, drug-free remission from a single dose.