{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-046978","form_type":"8-K","ticker":"KYNB","cik":"0000921299","company_name":"KYNTRA BIO, INC.","filed_at":"2025-03-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:06.817053+00:00","generated_at":"2026-05-24T02:47:06.130065+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FibroGen publishes Phase 1 FG-3246 mCRPC data in JCO; ORR 20%, DCR 80%, mid-2025 Phase 2 start","bullets":["Phase 1 study of FG-3246 (anti-CD46 ADC) in mCRPC published in Journal of Clinical Oncology.","Confirmed ORR 20%, DCR 80%, median rPFS 8.7 months in evaluable patients.","PSA50 response rate 36% in 39 evaluable patients; half of docetaxel-sensitive patients responded.","Safety profile consistent with MMAE ADCs; ocular AEs infrequent; MTD 2.7 mg/kg every 3 weeks.","Phase 2 monotherapy dose optimization to start by mid-2025; combo enzalutamide topline in 2H 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-046978","json":"https://secwatch.observer/filing/0000950170-25-046978.json","markdown":"https://secwatch.observer/filing/0000950170-25-046978.md","text":"https://secwatch.observer/filing/0000950170-25-046978.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/0000950170-25-046978-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/fgen-20250328.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T02:47:06.130065+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"}