{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-042598","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2025-11-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.803410+00:00","generated_at":"2026-05-16T18:42:02.429221+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"European Commission approves BRINSUPRI as first treatment for NCFB in EU","bullets":["EC approved BRINSUPRI (brensocatib 25 mg) for NCFB patients 12+ years with ≥2 exacerbations in prior 12 months.","First and only approved treatment for non-cystic fibrosis bronchiectasis in the EU; reviewed under accelerated assessment.","Phase 3 ASPEN study showed 19.4% reduction in annual exacerbation rate vs placebo; key secondary endpoints met.","Approval follows positive CHMP opinion on 16 Oct 2025; Insmed plans EU access starting early 2026.","Applications also under review in UK (MHRA) and Japan (PMDA)."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-042598","json":"https://secwatch.observer/filing/0001140361-25-042598.json","markdown":"https://secwatch.observer/filing/0001140361-25-042598.md","text":"https://secwatch.observer/filing/0001140361-25-042598.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125042598/0001140361-25-042598-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125042598/ef20059077_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T18:42:02.429221+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"}