{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-001245","form_type":"8-K","ticker":"OMER","cik":"0001285819","company_name":"OMEROS CORP","filed_at":"2025-01-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.187282+00:00","generated_at":"2026-05-27T23:46:50.371476+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":"Omeros narsoplimab sensitivity analyses confirm survival benefit; BLA resubmission planned this quarter","bullets":["Sensitivity analyses show HR 0.24–0.42 vs external control, p-values 0.0124 to <0.00001, confirming primary endpoint robustness.","Primary endpoint (Dec 19): HR=0.32 (95% CI 0.23–0.44), p<0.00001, over 3-fold mortality reduction in TA-TMA patients.","Omeros targets BLA resubmission to FDA later this quarter and European MAA submission by mid-year.","Narsoplimab has been well tolerated across trials with no safety signal of concern."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-001245","json":"https://secwatch.observer/filing/0001437749-25-001245.json","markdown":"https://secwatch.observer/filing/0001437749-25-001245.md","text":"https://secwatch.observer/filing/0001437749-25-001245.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925001245/0001437749-25-001245-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925001245/omer20250116c_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T23:46:50.371476+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"}