{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-038758","form_type":"8-K","ticker":"OMER","cik":"0001285819","company_name":"OMEROS CORP","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.030013+00:00","generated_at":"2026-05-16T12:04:40.836338+00:00","sec_items":["9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Omeros' YARTEMLEA as first therapy for TA-TMA; launch set for Jan 2026","bullets":["YARTEMLEA (narsoplimab-wuug) approved for adults and children ≥2 years with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).","Pivotal trial CR rate 61%, EAP CR rate 68%; 100-day survival 73% and 74% respectively; all patients high-risk.","No Boxed Warning or REMS; most common adverse reactions (≥20%) include viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, hypokalemia.","U.S. launch planned for January 2026; dedicated ICD-10 and procedure codes in place; YARTEMLEAssist patient support program expected in Q1 2026.","Marketing authorization application under EMA review with decision expected mid-2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-038758","json":"https://secwatch.observer/filing/0001437749-25-038758.json","markdown":"https://secwatch.observer/filing/0001437749-25-038758.md","text":"https://secwatch.observer/filing/0001437749-25-038758.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/0001437749-25-038758-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/omer20251218_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:04:40.836338+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"}