{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-010651","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2026-03-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.545112+00:00","generated_at":"2026-05-15T09:19:50.941990+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Insmed Reports Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE in MAC Lung Disease","bullets":["Primary endpoint met: change from baseline in Respiratory Symptom Score at Month 13 showed 17.77 vs 14.66 points (p=0.0299).","All multiplicity-controlled secondary culture conversion endpoints met: 87.8% vs 57.0% by Month 6, 84.7% vs 61.3% by Month 12 (p<0.0001).","Durable culture conversion at Month 15: 76.2% vs 47.6% (p<0.0001).","Plans to file sNDA in U.S. and submit data to PMDA in Japan in H2 2026 for potential label expansion.","Safety profile consistent with known ARIKAYCE profile; no new safety signals observed."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-010651","json":"https://secwatch.observer/filing/0001140361-26-010651.json","markdown":"https://secwatch.observer/filing/0001140361-26-010651.md","text":"https://secwatch.observer/filing/0001140361-26-010651.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036126010651/0001140361-26-010651-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036126010651/ef20068516_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-15T09:19:50.941990+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"}