{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-042505","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2023-09-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.150384+00:00","generated_at":"2026-06-10T23:45:02.921373+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Insmed Phase 3 ARISE study meets primary endpoint; ARIKAYCE shows strong culture conversion in MAC lung disease","bullets":["ARISE validated QOL-B respiratory domain as PRO tool; to be proposed as primary endpoint for ENCORE without modification.","ARIKAYCE arm achieved 78.8% culture conversion at Month 7 vs 47.1% for comparator (p=0.0010).","QOL-B respiratory score improvement trend: 12.24 vs 7.76 (p=0.1073); 43.8% of ARIKAYCE patients exceeded meaningful threshold.","No new safety signals; discontinuation rate 22.9% for ARIKAYCE vs 7.8% for comparator.","Insmed plans to explore accelerated filing for ARIKAYCE in newly infected MAC patients with global regulators."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-042505","json":"https://secwatch.observer/filing/0001140361-23-042505.json","markdown":"https://secwatch.observer/filing/0001140361-23-042505.md","text":"https://secwatch.observer/filing/0001140361-23-042505.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036123042505/0001140361-23-042505-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036123042505/brhc20058439_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T23:45:02.921373+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"}