{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-045111","form_type":"8-K","ticker":"KYNB","cik":"0000921299","company_name":"KYNTRA BIO, INC.","filed_at":"2023-08-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.036990+00:00","generated_at":"2026-06-11T02:45:08.644837+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FibroGen Phase 3 pamrevlumab trial for DMD fails to meet primary endpoint","bullets":["Primary endpoint (NSAA total score change at week 52) not met: mean difference -0.528 points (p=0.5553).","All secondary endpoints including stair climb velocity and 10-meter walk/run test also not met.","Pamrevlumab was generally safe and well tolerated; SAEs 8.3% pamrevlumab vs 2.8% placebo.","Company evaluating total data and will share full results at a future medical forum.","Interim CEO Thane Wettig expressed disappointment and gratitude to trial participants."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-045111","json":"https://secwatch.observer/filing/0000950170-23-045111.json","markdown":"https://secwatch.observer/filing/0000950170-23-045111.md","text":"https://secwatch.observer/filing/0000950170-23-045111.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/921299/000095017023045111/0000950170-23-045111-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/921299/000095017023045111/fgen-20230829.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T02:45:08.644837+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"}