{"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","discovered_at":"2026-05-14T18:03:15.326361+00:00","generated_at":"2026-05-31T20:51:49.889282+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Kyverna receives FDA RMAT designation for KYV-101 in refractory stiff-person syndrome","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-083570","json":"https://secwatch.observer/filing/0000950170-24-083570.json","markdown":"https://secwatch.observer/filing/0000950170-24-083570.md","text":"https://secwatch.observer/filing/0000950170-24-083570.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:51:49.889282+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}