{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-030011","form_type":"8-K","ticker":"PHAT","cik":"0001783183","company_name":"Phathom Pharmaceuticals, Inc.","filed_at":"2023-02-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.524146+00:00","generated_at":"2026-06-19T20:43:26.977868+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Phathom receives FDA complete response letters for vonoprazan NDAs due to nitrosamine impurity","bullets":["CRL for erosive esophagitis NDA and H. pylori post-approval supplement, citing impurity N-nitroso-vonoprazan (NVP).","FDA requests additional stability data showing NVP remains below acceptable intake throughout shelf life; no other deficiencies.","Phathom implemented mitigation measures and expects to meet with FDA in Q1 2023 to discuss resubmission timeline.","This follows January 2023 announcement; delays potential approval and commercial launch of vonoprazan products."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-030011","json":"https://secwatch.observer/filing/0001193125-23-030011.json","markdown":"https://secwatch.observer/filing/0001193125-23-030011.md","text":"https://secwatch.observer/filing/0001193125-23-030011.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523030011/0001193125-23-030011-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1783183/000119312523030011/d426711d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T20:43:26.977868+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"}