{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-022879","form_type":"8-K","ticker":"KYNB","cik":"0000921299","company_name":"KYNTRA BIO, INC.","filed_at":"2023-05-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:42.821540+00:00","generated_at":"2026-06-14T22:01:05.144435+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FibroGen announces positive Phase 3 results for roxadustat in chemotherapy-induced anemia in China","bullets":["Met primary endpoint: noninferiority to erythropoietin alfa in hemoglobin change from baseline to average weeks 9-13.","Plan to file supplemental New Drug Application in China with AstraZeneca collaboration.","159 non-myeloid malignancy patients enrolled; roxadustat dosed three times weekly for 12 weeks.","Adverse event profile consistent with prior studies, supporting positive benefit-risk.","Detailed results to be presented at an upcoming medical conference."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-022879","json":"https://secwatch.observer/filing/0000950170-23-022879.json","markdown":"https://secwatch.observer/filing/0000950170-23-022879.md","text":"https://secwatch.observer/filing/0000950170-23-022879.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/921299/000095017023022879/0000950170-23-022879-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/921299/000095017023022879/fgen-20230518.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T22:01:05.144435+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"}