{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-030537","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2025-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.351222+00:00","generated_at":"2026-05-17T14:16:13.465697+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Insmed receives FDA approval for BRINSUPRI (brensocatib), first treatment for NCFB","bullets":["FDA approved BRINSUPRI 10 mg and 25 mg for non-CF bronchiectasis in adults and children ≥12 years.","Phase 3 ASPEN: 21.1% (10 mg) and 19.4% (25 mg) reduction in annual exacerbation rate vs placebo.","Approximately 500,000 U.S. patients diagnosed with NCFB; first approved therapy for this condition.","BRINSUPRI available by prescription via specialty pharmacy; commercial launches in EU/UK/Japan expected 2026.","Insmed to host investor call today at 12:00 PM ET to discuss the approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-030537","json":"https://secwatch.observer/filing/0001140361-25-030537.json","markdown":"https://secwatch.observer/filing/0001140361-25-030537.md","text":"https://secwatch.observer/filing/0001140361-25-030537.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125030537/0001140361-25-030537-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125030537/ef20053490_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T14:16:13.465697+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"}