{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-21-013245","form_type":"8-K","ticker":"OMER","cik":"0001285819","company_name":"OMEROS CORP","filed_at":"2021-10-18T23:59:59+00:00","discovered_at":"2026-05-14T18:04:11.906540+00:00","generated_at":"2026-06-28T20:13:32.644294+00:00","sec_items":["5.02","7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Omeros receives FDA Complete Response Letter for narsoplimab BLA; director Ray Aspiri retires","bullets":["Ray Aspiri retired from Omeros board effective Oct 14, 2021, with no disagreement with the company.","FDA issued a Complete Response Letter for narsoplimab BLA for HSCT-TMA, citing difficulty estimating treatment effect.","FDA stated additional information is needed to support regulatory approval of narsoplimab for HSCT-TMA.","No CMC, safety, or non-clinical issues precluding approval were raised in the FDA Complete Response Letter.","Omeros plans to request a Type A meeting with FDA to discuss the most expeditious path for narsoplimab approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-21-013245","json":"https://secwatch.observer/filing/0001558370-21-013245.json","markdown":"https://secwatch.observer/filing/0001558370-21-013245.md","text":"https://secwatch.observer/filing/0001558370-21-013245.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/0001558370-21-013245-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/omer-20211014x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T20:13:32.644294+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":[{"claim_id":"6b0e570d68","claim":"Ray Aspiri retired as Director at OMEROS CORP.","evidence_excerpt":"Ray Aspiri has retired from the board of directors of Omeros Corporation (the “Company”).","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/0001558370-21-013245-index.htm","confidence":1.0,"family_label":"Executive change","details":[{"label":"Action","value":"retired"},{"label":"Role","value":"Director"}],"fact_type":"executive_change"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}