{"schema_version":"secwatch.filing_event.v1","accession":"0001728117-26-000104","form_type":"8-K","ticker":"GOSS","cik":"0001728117","company_name":"Gossamer Bio, Inc.","filed_at":"2026-09-23T20:05:41+00:00","discovered_at":"2026-09-23T20:07:10.776095+00:00","generated_at":"2026-09-23T20:09:11.650217+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Gossamer Bio submits NDA for seralutinib in PAH; FDA acceptance decision expected later 2026","bullets":["Submitted NDA to FDA on Sept 23, 2026 for seralutinib treatment of pulmonary arterial hypertension.","First NDA submission; supported by Phase 3 PROSERA and Phase 2 TORREY studies.","FDA minutes from June 2026 Pre-NDA meeting called statistical significance a review issue, not filing issue.","Company expects FDA acceptance decision for filing later this year; approval uncertain."],"urls":{"canonical":"https://secwatch.observer/filing/0001728117-26-000104","json":"https://secwatch.observer/filing/0001728117-26-000104.json","markdown":"https://secwatch.observer/filing/0001728117-26-000104.md","text":"https://secwatch.observer/filing/0001728117-26-000104.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1728117/000172811726000104/0001728117-26-000104-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1728117/000172811726000104/goss-20260923.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-23T20:09:11.650217+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"}