{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-090354","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2023-04-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.547772+00:00","generated_at":"2026-06-17T06:33:28.938908+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Phathom provides regulatory update on path to resubmit EE NDA in Q2 2023; launch expected Q4 2023","bullets":["Met with FDA; CRLs solely related to nitrosamine impurity NVP; mitigation includes minor tablet reformulation.","Stability data shared with FDA; anticipates resubmitting EE NDA in Q2 2023, with combined EE/H. pylori launch in Q4 2023.","Also plans to submit PAS for H. pylori; FDA action expected in Q4 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-090354","json":"https://secwatch.observer/filing/0001193125-23-090354.json","markdown":"https://secwatch.observer/filing/0001193125-23-090354.md","text":"https://secwatch.observer/filing/0001193125-23-090354.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/0001193125-23-090354-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/d495312d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T06:33:28.938908+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"}