{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-014815","form_type":"8-K","ticker":"OMER","cik":"0001285819","company_name":"OMEROS CORP","filed_at":"2025-05-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.838516+00:00","generated_at":"2026-05-22T11:07:04.862916+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Omeros announces FDA accepts BLA resubmission for narsoplimab in TA-TMA; PDUFA late Sept 2025","bullets":["FDA accepted Class 2 resubmission of BLA for narsoplimab for TA-TMA; PDUFA target action date late September 2025.","Resubmission includes survival analyses comparing narsoplimab-treated patients to external control, showing statistically significant improvement.","Also includes data from expanded access program in adult and pediatric TA-TMA patients.","Omeros is preparing MAA for submission to European Medicines Agency later this quarter.","Company responding to FDA information requests; expects interactive review."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-014815","json":"https://secwatch.observer/filing/0001437749-25-014815.json","markdown":"https://secwatch.observer/filing/0001437749-25-014815.md","text":"https://secwatch.observer/filing/0001437749-25-014815.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925014815/0001437749-25-014815-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1285819/000143774925014815/omer20250506_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T11:07:04.862916+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"}