{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-005570","form_type":"8-K","ticker":"INSM","cik":"0001104506","company_name":"INSMED Inc","filed_at":"2025-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:02.941889+00:00","generated_at":"2026-05-26T05:26:59.518754+00:00","sec_items":["8.01","7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA will not hold AdComm for Insmed's brensocatib; PDUFA date Aug 12, 2025","bullets":["FDA communicated in Day 74 letter no advisory committee meeting is currently planned.","Priority review reaffirmed with PDUFA target action date of August 12, 2025.","NDA for non-CF bronchiectasis is based on data from the Phase 3 ASPEN study.","Brensocatib could be the first approved treatment for bronchiectasis and first DPP1 inhibitor."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-005570","json":"https://secwatch.observer/filing/0001140361-25-005570.json","markdown":"https://secwatch.observer/filing/0001140361-25-005570.md","text":"https://secwatch.observer/filing/0001140361-25-005570.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125005570/0001140361-25-005570-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1104506/000114036125005570/ef20044166_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T05:26:59.518754+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"}