{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-318377","form_type":"8-K","ticker":"KYTX","cik":"0001994702","company_name":"Kyverna Therapeutics, Inc.","filed_at":"2025-12-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.239961+00:00","generated_at":"2026-05-16T13:16:11.849668+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Kyverna reports positive Phase 2 topline data for miv-cel in stiff person syndrome; BLA planned 1H 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-318377","json":"https://secwatch.observer/filing/0001193125-25-318377.json","markdown":"https://secwatch.observer/filing/0001193125-25-318377.md","text":"https://secwatch.observer/filing/0001193125-25-318377.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1994702/000119312525318377/0001193125-25-318377-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1994702/000119312525318377/d285116d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:16:11.849668+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"}