Kyverna receives FDA RMAT designation for KYV-101 in refractory stiff-person syndrome

Kyverna Therapeutics, Inc.

FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for KYV-101, an autologous CD19 CAR T-cell therapy.
Designation based on positive clinical outcomes from named-patient use in Germany for refractory stiff-person syndrome (SPS).
RMAT enables accelerated development, senior FDA guidance, and use of surrogate endpoints for potential approval.
Kyverna plans to initiate KYSA-8 trial; quote from investigator: 'could drastically change treatment landscape for SPS.'
CEO Peter Maag highlighted potential for durable, immunosuppressant-free remission in SPS patients.

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