---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-083570"
form_type: "8-K"
ticker: "KYTX"
cik: "0001994702"
company_name: "Kyverna Therapeutics, Inc."
filed_at: "2024-07-15T23:59:59+00:00"
generated_at: "2026-05-31T20:51:49.889282+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-083570
- form_type: 8-K
- ticker: KYTX
- cik: 0001994702
- company_name: Kyverna Therapeutics, Inc.
- filed_at: 2024-07-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1994702/000095017024083570/0000950170-24-083570-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1994702/000095017024083570/kytx-20240715.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-083570
- JSON: https://secwatch.observer/filing/0000950170-24-083570.json
- Plain text: https://secwatch.observer/filing/0000950170-24-083570.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.