{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-027535","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2024-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.301259+00:00","generated_at":"2026-06-01T07:54:00.451415+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"Insmed Announces Positive Topline Results from Phase 3 ASPEN Study of Brensocatib in Bronchiectasis","bullets":["ASPEN Phase 3 met primary endpoint: brensocatib 10mg and 25mg reduced annualized pulmonary exacerbations by 21.1% (p=0.0019) and 19.4% (p=0.0046) vs placebo.","Brensocatib achieved statistical significance on multiple secondary endpoints including prolongation of time to first PE and odds of remaining exacerbation-free.","Insmed plans to file NDA with FDA in Q4 2024; anticipates U.S. launch mid-2025, Europe/Japan launches first half 2026.","If approved, brensocatib would be first approved treatment for bronchiectasis and first DPP1 inhibitor for neutrophil-mediated diseases.","Brensocatib well-tolerated; severe TEAEs occurred in 12.7% (10mg), 11.7% (25mg), and 16.0% (placebo) with lower serious TEAE rates than placebo."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-027535","json":"https://secwatch.observer/filing/0001140361-24-027535.json","markdown":"https://secwatch.observer/filing/0001140361-24-027535.md","text":"https://secwatch.observer/filing/0001140361-24-027535.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036124027535/0001140361-24-027535-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036124027535/ef20030032_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:54:00.451415+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"}