{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-000749","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2023-01-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.523723+00:00","generated_at":"2026-06-20T20:58:24.546071+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA delays action on Phathom's vonoprazan EE NDA; nitrosamine impurity data required, launch pushed past Q1 2023","bullets":["FDA will not act by Jan 11, 2023 PDUFA date for vonoprazan erosive esophagitis NDA.","Acceptable daily intake for nitrosamine impurity NVP set at 96 ng/day; additional stability data required.","Phathom no longer expects product launches for H. pylori or EE in Q1 2023.","Company is generating additional stability data and discussing nature/extent with FDA.","Previously identified NVP impurity in commercial batches delays both indications."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-000749","json":"https://secwatch.observer/filing/0001193125-23-000749.json","markdown":"https://secwatch.observer/filing/0001193125-23-000749.md","text":"https://secwatch.observer/filing/0001193125-23-000749.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/0001193125-23-000749-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523000749/d277519d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T20:58:24.546071+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"}