{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-21-012911","form_type":"8-K","ticker":"OMER","cik":"0001285819","company_name":"OMEROS CORP","filed_at":"2021-10-01T23:59:59+00:00","discovered_at":"2026-05-14T18:04:11.906325+00:00","generated_at":"2026-06-28T23:48:36.362295+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Omeros receives FDA deficiency notice for narsoplimab BLA; PDUFA date expected to be missed","bullets":["FDA identified deficiencies in narsoplimab BLA for HSCT-TMA, precluding labeling/post-marketing discussions.","Resolution not expected by Oct 17, 2021 PDUFA target action date; FDA expressed intent to work with Omeros.","No specific deficiencies disclosed; Omeros evaluating next steps for HSCT-TMA, a lethal condition with no approved therapy.","Narsoplimab has Breakthrough Therapy and Orphan designations; first BLA submitted for HSCT-TMA."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-21-012911","json":"https://secwatch.observer/filing/0001558370-21-012911.json","markdown":"https://secwatch.observer/filing/0001558370-21-012911.md","text":"https://secwatch.observer/filing/0001558370-21-012911.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1285819/000155837021012911/0001558370-21-012911-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1285819/000155837021012911/omer-20211001x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T23:48:36.362295+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"}