Kyverna reports positive Phase 2 topline data for miv-cel in stiff person syndrome; BLA planned 1H 2026

Kyverna Therapeutics, Inc.

Primary endpoint met: 46% median improvement in timed 25-foot walk at Week 16 (p=0.0002).
81% of patients exceeded 20% improvement in T25FW; 67% no longer needed walking aid (12 patients).
All secondary endpoints statistically significant (p<0.0001); 100% free of immunotherapies post-dose.
No high-grade CRS or ICANS; manageable Grade 3/4 neutropenia observed in some patients.
Company plans to submit BLA to FDA for SPS in first half of 2026; RMAT and Orphan Drug designations.

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